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COAPT trial

A trial in 614 people with heart failure and a leaking mitral valve caused by the weak heart muscle, who still had symptoms on maximal medicines. Adding the MitraClip device to medicines led to fewer hospital stays for heart failure and fewer deaths within two years than medicines alone. It was paid for by Abbott, the FDA applicant for the device, and the registry lists no masking.

Also called COAPT · Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group, open-label trial of transcatheter mitral-valve repair plus medical therapy versus medical therapy alone. The registry records allocation as randomized, intervention model as parallel and masking as none, and adds a continued access group.
Phase
Not applicable
Enrolled
  • 776 participants (enrolled count) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, retrieved )
  • 614 patients (enrolled count) (Transcatheter Mitral-Valve Repair in Patients with Heart Failure, retrieved )
Sponsor
  • Abbott Lead sponsor on the registry record
Funder
  • Abbott Funder named in the abstract
Registry
  • NCT NCT01626079
Started
(actual) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, retrieved )
Primary completion
(actual) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, retrieved )
Completion
(anticipated) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, retrieved )
Results first posted
(actual) (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, retrieved )
Countries
United States, Canada (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS, retrieved )
Care setting
78 sites in the United States and Canada (abstract). (Transcatheter Mitral-Valve Repair in Patients with Heart Failure, retrieved )
Registry status
  • “UNKNOWN” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Registry NCT01626079 (Abbott Medical Devices lead sponsor, class industry, status unknown, estimated completion 2024-07 which is out of date). Randomized, parallel, no masking, treatment. The registry count (776) includes a continued access study (COAPT CAS, 162 patients); the paper reports 614 enrolled. Abstract: annualized heart-failure hospitalizations 35.8% versus 67.9% per patient-year (hazard ratio 0.53); death within 24 months 29.1% versus 46.1% (hazard ratio 0.62). Findings tabulated: death only, because the hospitalization end point has no outcome record in this atlas.

Arms

  • MitraClip plus medical therapy

    Intervention MitraClip

    Percutaneous mitral valve repair using the MitraClip System, with maximal guideline-directed medical therapy (registry and abstract).

  • Medical therapy alone

    Intervention None named

    Patients managed non-surgically based on standard hospital clinical practice (registry control group); medical therapy alone (abstract). No separate intervention record exists for this comparison.

Findings

Findings are grouped by the claim they support. Each group keeps its own population and follow-up, and each finding keeps its own denominator and time window. Not reported is not zero, and findings from different contexts are not combined.

In plain words

In COAPT, death from any cause within 24 months occurred in 29.1% of the patients in the MitraClip plus medicines group and in 46.1% of the patients in the medicines alone group (hazard ratio 0.62, 95% confidence interval 0.46 to 0.82).

Applies to Adult
  • Patients 18 years or older (registry minimum age) with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite maximal doses of guideline-directed medical therapy; 614 were randomized (302 to the device group and 312 to the control group). The registry record also covers a continued access study of 162 further patients. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
  • 78 sites in the United States and Canada (abstract)
  • United States and Canada
  • Registry minimum age 18 years; no maximum age
Follow-up The primary effectiveness end point covers 24 months; the primary safety end point is at 12 months (abstract). The registry gives the primary completion as 2019-03 and an estimated study completion of 2024-07, with a recruitment status of unknown.

Death from any cause Endpoint role not specified

  1. MitraClip plus medical therapy arm

    Measure
    Death from any cause within 24 months (percent of patients)
    Value
    29.1 percent
    Reported as
    29.1% of the patients in the device group
    Interval
    Not applicable
    Denominator
    Not reported (basis: Percentage of the patients in the group; 302 were randomized to the device group and 312 to the control group (abstract). No event counts are given.)
    Time window
    Within 24 months of follow-up (abstract)

  2. Medical therapy alone arm

    Measure
    Death from any cause within 24 months (percent of patients)
    Value
    46.1 percent
    Reported as
    46.1% of the patients in the control group
    Interval
    Not applicable
    Denominator
    Not reported (basis: Percentage of the patients in the group; 302 were randomized to the device group and 312 to the control group (abstract). No event counts are given.)
    Time window
    Within 24 months of follow-up (abstract)

  3. MitraClip plus medical therapy compared with Medical therapy alone

    Measure
    Hazard ratio, device versus control
    Value
    0.62 ratio
    Reported as
    hazard ratio 0.62; 95% CI, 0.46 to 0.82; P<0.001
    Interval
    0.46 to 0.82 (95% confidence interval)
    Denominator
    Not applicable (basis: Comparison of the two per-arm rows (302 versus 312 randomized))
    Time window
    Within 24 months of follow-up (abstract)

Caveats

  • Limitations. The abstract does not name death from any cause among the end points in its methods; it reports 24-month death as a result. The registry lists all-cause mortality among its secondary outcomes (a count at 12 months, and Kaplan-Meier freedom from all-cause mortality at 24 months). The abstract does not say whether this test was prespecified or adjusted for multiple comparisons, so treat it as a secondary result. The same limits apply as for the heart-failure hospitalization claim: funded by Abbott, no masking in the registry, selected patients with secondary mitral regurgitation on maximal medicines. Only the abstract was read.

Sources and citations (4)

  1. Supports Transcatheter Mitral-Valve Repair in Patients with Heart Failure

    Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2018-12-13 · DOI: 10.1056/NEJMoa1806640 · PMID: 30280640

    Locator
    Abstract, RESULTS, sentence 4
    How it applies
    Death from any cause by group, and the hazard ratio.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49
    Reuse basis
    PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  2. Supports Transcatheter Mitral-Valve Repair in Patients with Heart Failure

    Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2018-12-13 · DOI: 10.1056/NEJMoa1806640 · PMID: 30280640

    Locator
    Abstract, CONCLUSIONS, sentence 1
    How it applies
    The authors report lower all-cause mortality within 24 months.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    fbce32e5ae83b5fb62a7a20edcaa6e60f7ee6032538ecc9dcb2642900f057d49
    Reuse basis
    PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  3. Background Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

    Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2023-11-27. · NCT: NCT01626079

    Locator
    protocolSection.outcomesModule.secondaryOutcomes[24].measure
    How it applies
    The registry lists all-cause mortality at 12 months among its secondary outcomes.
    Retrieved
    Source effective date
    2023-11-27
    Source state
    Current
    Snapshot hash
    c704470d9e281e9b6ab5a19cc4735faa44c97e48e3d57e3fbc41ed6c84710da1
    Reuse basis
    Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT01626079.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

  4. Background Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

    Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2023-11-27. · NCT: NCT01626079

    Locator
    protocolSection.outcomesModule.secondaryOutcomes[48].measure
    How it applies
    The registry also lists Kaplan-Meier freedom from all-cause mortality as a secondary outcome.
    Retrieved
    Source effective date
    2023-11-27
    Source state
    Current
    Snapshot hash
    c704470d9e281e9b6ab5a19cc4735faa44c97e48e3d57e3fbc41ed6c84710da1
    Reuse basis
    Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT01626079.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

Record details

Record id
cardio:coapt
Content hash
5847521785cb4ab2e2d577bc52481472d82d348df9c11da7ab28c60ce37eeb8f