# WATCHMAN left atrial appendage closure device Product · id `cardio:watchman` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: WATCHMAN Browse, organ or system: Heart Browse, condition area: Stroke; Heart rhythm problems ## In plain language A device used to seal the left atrial appendage (a pouch off the upper left chamber of the heart) so that clots cannot form there and cause a stroke. In the PROTECT AF trial it was placed by percutaneous closure. The US Food and Drug Administration approved it in March 2015 for people with non-valvular atrial fibrillation who are at higher risk of stroke, are recommended for blood thinners, are suitable for warfarin, and have a reason to look for a non-drug alternative. In the PROTECT AF trial the device did not do worse than warfarin for the main outcome, and it had more serious safety events, mostly linked to the procedure. ## Technical summary FDA premarket approval P130013, decided 2015-03-13 (received 2013-05-14), applicant Boston Scientific Corp, product code NGV, device class 3, expedited review. The openFDA record holds the original approval and many later supplements, including newer device versions; this page covers the original approval and the PROTECT AF evidence on the first device version. The openFDA registration and listing records name Boston Scientific Corporation as a manufacturing establishment for the P130013 devices; that listing is current and does not show who made the first device in 2015. ## Claims, with the population each applies to ## Context: United States premarket approval P130013 for the WATCHMAN left atrial appendage closure technology Recipient: Recipient not specified; Population: People with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASC scores and are recommended for anticoagulation therapy, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin (the wording of the openFDA approval order statement).; Care setting: Not stated in the FDA record; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the FDA record (it says people with non-valvular atrial fibrillation and gives no age); Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) ### The US Food and Drug Administration approved premarket approval application P130013 for the WATCHMAN left atrial appendage closure technology on 13 March 2015, after receiving it on 14 May 2013. The openFDA record names Boston Scientific Corp as applicant and gives product code NGV, device class 3 and an expedited review flag of Y. Its approval-order statement says the device is intended to lower the risk of thromboembolism from the left atrial appendage in people with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism by CHADS2 or CHA2DS2-VASC score and are recommended for anticoagulation therapy, who are deemed by their physicians to be suitable for warfarin, and who have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account how safe and effective the device is compared with warfarin. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: Recipient: Recipient not specified; Population: People with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASC scores and are recommended for anticoagulation therapy, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin (the wording of the openFDA approval order statement).; Care setting: Not stated in the FDA record; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the FDA record (it says people with non-valvular atrial fibrillation and gives no age); Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) - Limitations: This is the original approval; the openFDA data hold many later supplements to P130013, including newer device versions, which are not described here. The approval wording ties the device to people who are suitable for warfarin and have a rationale to seek an alternative. It is not a statement that the device is better than warfarin. PROTECT AF tested the first device version. openFDA data are unvalidated. - Last checked: 2026-10-14 - Sources: 1. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].pma\_number. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: PMA number. 2. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].applicant. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: The applicant. 3. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].trade\_name. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Trade name of the device. 4. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].decision\_date. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Decision date. 5. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].date\_received. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Date FDA received the application. 6. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].decision\_code. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Decision code APPR. 7. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].product\_code. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Product code. 8. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].openfda.device\_class. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Device class as the openFDA block writes it. 9. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].expedited\_review\_flag. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Expedited review flag. 10. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].ao\_statement. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Approval-order statement, part 1. 11. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].ao\_statement (passage 2). Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Approval-order statement, part 2. 12. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].ao\_statement (passage 3). Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Approval-order statement, part 3. 13. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].ao\_statement (passage 4). Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Approval-order statement, part 4. 14. Supports: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: results\[0\].ao\_statement (passage 5). Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: Approval-order statement, part 5. 15. Background: FDA premarket approval P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (openFDA record of the original approval) (Regulator, edition The openFDA PMA record for the original approval (decision date 2015-03-13), selected from the 85 records of P130013 (the original and its supplements) by its decision date. Dataset last updated 2026-10-05.) Locator: meta.disclaimer. Retrieved 2026-10-14T18:21:03Z. Source state: Current. Snapshot hash: fd4d014d0a13d8ac7714d7db917cc79df553608b883528496eb4221c12d22670. How it applies: openFDA's own disclaimer about relying on its data. ## Context: Adults with non-valvular atrial fibrillation who were eligible for long-term warfarin (PROTECT AF) Recipient: Adult; Population: Adults with paroxysmal, persistent or permanent non-valvular atrial fibrillation who were eligible for long-term warfarin and had at least one of: previous stroke or transient ischemic attack, congestive heart failure, diabetes, hypertension, or age 75 or older (abstract wording; the registry gives a CHADS score of 1 or more).; Care setting: Not stated in the abstract or the registry record; Geography: Registry sites in the United States, Czechia and Germany; Life stage: Adults aged 18 or older (registry minimum age); Follow-up: The abstract gives 1065 patient-years of follow-up. The registry lists the primary completion as 2013-08. ### In PROTECT AF, a multicentre, randomised non-inferiority trial, 707 eligible adults with non-valvular atrial fibrillation were randomly assigned 2:1 to percutaneous closure of the left atrial appendage with the WATCHMAN device and subsequent discontinuation of warfarin (463 patients) or to warfarin with a target international normalised ratio of 2.0 to 3.0 (244 patients). Analysis was by intention to treat. At 1065 patient-years of follow-up, the primary efficacy event rate (a composite of stroke, cardiovascular death and systemic embolism) was 3.0 per 100 patient-years (95% credible interval 1.9 to 4.5) in the device group and 4.9 per 100 patient-years (2.8 to 7.1) in the warfarin group (rate ratio 0.62, 95% credible interval 0.35 to 1.25, which includes 1). The probability of non-inferiority was more than 99.9%. Primary safety events (major bleeding, pericardial effusion and device embolisation) were more frequent in the device group, 7.4 per 100 patient-years (95% credible interval 5.5 to 9.7), than in the control group, 4.4 per 100 patient-years (2.5 to 6.7) (rate ratio 1.69, 1.01 to 3.19). The authors write that the safety events in the device group were mainly a result of periprocedural complications. - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: Recipient: Adult; Population: Adults with paroxysmal, persistent or permanent non-valvular atrial fibrillation who were eligible for long-term warfarin and had at least one of: previous stroke or transient ischemic attack, congestive heart failure, diabetes, hypertension, or age 75 or older (abstract wording; the registry gives a CHADS score of 1 or more).; Care setting: Not stated in the abstract or the registry record; Geography: Registry sites in the United States, Czechia and Germany; Life stage: Adults aged 18 or older (registry minimum age); Follow-up: The abstract gives 1065 patient-years of follow-up. The registry lists the primary completion as 2013-08. - Limitations: Abstract of the 2009 report only; the full text was not read. The result is for the first device in the trial, not for later WATCHMAN versions. The intervals are Bayesian 95% credible intervals, and the trial tested non-inferiority with a two-fold margin. The interval for the efficacy rate ratio (0.35 to 1.25) includes 1, so the trial does not show that the device was better than warfarin. Primary safety events were higher with the device (rate ratio 1.69). The trial enrolled people who were eligible for warfarin, so it does not test the device in people who cannot take blood thinners. The abstract names Atritech as funder, while the registry lists Boston Scientific Corporation as lead sponsor; the sources do not explain the difference. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) and Crossref lists an erratum notice (doi 10.1016/S0140-6736(09)61953-X); neither was read, so the numbers may not match the corrected paper. The registry enrollment (800) includes non-randomized roll-in participants that the abstract does not count among the 707 randomized. - Last checked: 2026-10-14 - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 1, fragment 1. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Population (first fragment). 2. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 1, fragment 2. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Eligibility risk factors (second fragment). 3. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 1, fragment 3. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Eligibility age (third fragment). 4. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 2, fragment 1. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Randomization and intervention arm (first fragment). 5. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 2, fragment 2. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Control arm (second fragment). 6. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 3. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Primary efficacy composite. 7. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 4. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Non-inferiority criterion. 8. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 5. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Primary safety endpoint. 9. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 6. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Intention-to-treat analysis. 10. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, FINDINGS, sentence 1, fragment 1. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Efficacy event rates (first fragment). 11. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, FINDINGS, sentence 1, fragment 2. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Efficacy rate ratio (second fragment). 12. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, FINDINGS, sentence 2. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Probability of non-inferiority. 13. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, FINDINGS, sentence 3, fragment 1. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Primary safety events (first fragment). 14. Supports: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, FINDINGS, sentence 3, fragment 2. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Primary safety events (second fragment). 15. Background: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, INTERPRETATION, sentence 1. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: The authors' interpretation: non-inferior efficacy. 16. Background: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, INTERPRETATION, sentence 2, fragment 2. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: The authors' reading of the safety events. 17. Background: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: Abstract, FUNDING. Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: Funder named in the abstract. 18. Background: Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (Lancet 2009 Nov 7;374(9701):1596) that was not read, so the source state is corrected.) Locator: PubMed record, CommentsCorrections (ErratumIn). Retrieved 2026-10-14T18:18:40Z. Source state: Corrected. Snapshot hash: ae1a4b92d513fd39f7641f7d3ba1064aecb46f6b32da09ea485e00c023c87b77. How it applies: PubMed links a published erratum whose content was not read. 19. Background: Crossref record of the PROTECT AF paper (10.1016/S0140-6736(09)61343-X) (Dataset, edition Crossref works response fetched 2026-10-14 as cf-crossref-S0140-6736-09-61343-X.json. It lists an erratum notice that updates the paper.) Locator: message.updated-by\[0\].DOI. Retrieved 2026-10-14T19:20:01Z. Source state: Current. Snapshot hash: 0d4ab84a37f884c038a1c3af9e6ed5c30bf5dde9687d005b61da74ea93d83831. How it applies: Crossref lists an erratum notice, DOI 10.1016/S0140-6736(09)61953-X, that updates the paper. Its text was not read. 20. Background: WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) (Registry, edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2015-05-15.) Locator: protocolSection.designModule.enrollmentInfo.count. Retrieved 2026-10-14T18:18:37Z. Source state: Current. Snapshot hash: a7a1a7fd66cd0be9999cb7ebe0ce22652b54b7ab1ba0f1c97b987b0455dc517f. How it applies: Registry enrollment count, which includes roll-in participants. 21. Background: WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) (Registry, edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2015-05-15.) Locator: protocolSection.sponsorCollaboratorsModule.leadSponsor.name. Retrieved 2026-10-14T18:18:37Z. Source state: Current. Snapshot hash: a7a1a7fd66cd0be9999cb7ebe0ce22652b54b7ab1ba0f1c97b987b0455dc517f. How it applies: Registry lead sponsor. 22. Background: WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) (Registry, edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2015-05-15.) Locator: protocolSection.armsInterventionsModule.armGroups\[2\].description. Retrieved 2026-10-14T18:18:37Z. Source state: Current. Snapshot hash: a7a1a7fd66cd0be9999cb7ebe0ce22652b54b7ab1ba0f1c97b987b0455dc517f. How it applies: Registry description of the roll-in group. ## Guidance, authorization and access ### Regulatory decision `cardio:regdec-fda-p130013` - Product: WATCHMAN left atrial appendage closure device (`cardio:watchman`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2015-03-13 - Product version: Not stated in the FDA record (the original approval; later supplements cover newer versions) - Pathway: PMA - Submission: P130013 - Product code: NGV - Device class: III - Indication: To reduce the risk of thromboembolism from the left atrial appendage in people with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism, are recommended for anticoagulation therapy, are deemed suitable for warfarin and have an appropriate rationale to seek a non-pharmacologic alternative (openFDA approval-order statement, summarized) - Jurisdictions: United States; note: United States - Applies to: Recipient: Recipient not specified; Population: People with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASC scores and are recommended for anticoagulation therapy, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin (the wording of the openFDA approval order statement).; Care setting: Not stated in the FDA record; Geography: United States (decision by the US Food and Drug Administration); Life stage: Not stated in the FDA record (it says people with non-valvular atrial fibrillation and gives no age); Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory decision) - Basis: claim `cardio:claim-fda-p130013-approval` ## Connected pages - Percutaneous left atrial appendage closure: Left atrial appendage occlusion (`cardio:left-atrial-appendage-occlusion`) - Registered as a manufacturing establishment for the P130013 devices in the current openFDA listing; also the applicant on PMA P130013: Boston Scientific (`cardio:boston-scientific`) - Compared with warfarin in PROTECT AF: Atrial fibrillation (AF) (`cardio:atrial-fibrillation`) [a claim, not a settled fact; see claim `cardio:claim-protect-af-watchman-vs-warfarin` and its context] - Filed under this front: Procedures and surgery (`cardio:front-procedures-and-surgery`) - Investigated in: PROTECT AF (`cardio:protect-af`) ## Provenance Content hash: 25fc861d91d8bcb02d31b3c5809932feff83a7224ef1f40c4332690373631ddd Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14