{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:protect-af",
  "owner": "cardio",
  "kind": "study",
  "slug": "protect-af",
  "name": "PROTECT AF",
  "aliases": [
    "WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A trial that compared closing off the left atrial appendage with the WATCHMAN device against warfarin, in adults with non-valvular atrial fibrillation who were eligible for warfarin. For stroke, cardiovascular death and clots elsewhere in the body, the device group did not do worse than the warfarin group. Serious safety events, mostly linked to the procedure, were more common with the device.",
  "summary_technical": "ClinicalTrials.gov NCT00129545, a randomized, parallel-group study with no masking, listed with phases 2 and 3, sponsored by Boston Scientific Corporation, completed 2014-05. The main report is Holmes et al. 2009;374(9689):534-42 (abstract read only; the journal is on the cited PubMed record). The abstract names Atritech as funder; the registry lists Boston Scientific Corporation as lead sponsor, and the sources do not say how the two relate. PubMed links an erratum (2009 Nov 7;374(9701):1596) that was not read. Enrollment differs by source: the registry gives 800, which includes up to three non-randomized roll-in subjects per site, and the abstract says 707 eligible patients were randomly assigned; this is a difference in what is counted, and is not reconciled further. The registry start and completion dates carry no actual-or-estimated type for the start. No structured findings are recorded here; the numbers are on the claim.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT00129545",
      "normalized_value": "NCT00129545",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "arrhythmias",
        "stroke"
      ]
    }
  },
  "payload": {
    "design": "Multicentre, randomized, non-inferiority trial with unmasked allocation 2:1 to the device or warfarin, plus a non-randomized roll-in group (registry). Analysis by intention to treat (abstract).",
    "drug_phase": "2/3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2005-02",
      "type": null,
      "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2013-08",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
    },
    "completion_date": {
      "date": "2014-05",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
    },
    "results_first_posted": {
      "date": "2015-05-15",
      "type": null,
      "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
      },
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 800,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct00129545-2026-10-14"
      },
      {
        "count": 707,
        "basis": "randomized",
        "unit": "patients",
        "snapshot": "cardio:pubmed-19683639-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:protect-af-arm-watchman",
        "label": "WATCHMAN",
        "intervention": "cardio:watchman",
        "description": "Percutaneous closure of the left atrial appendage with the device and subsequent discontinuation of warfarin (abstract), 463 patients."
      },
      {
        "id": "cardio:protect-af-arm-warfarin",
        "label": "Warfarin control",
        "intervention": null,
        "description": "Warfarin with a target international normalised ratio between 2.0 and 3.0 (abstract), 244 patients. No separate entity is recorded for warfarin."
      },
      {
        "id": "cardio:protect-af-arm-roll-in",
        "label": "Roll-in",
        "intervention": null,
        "description": "Device implant in non-randomized subjects, up to three per site, who were not included in the primary analysis (registry)."
      }
    ],
    "findings": []
  },
  "content_digest": "23fbdfc7ef2187d71fb49829b5160a629fa4bf4837564168349a896fd249f9fe",
  "review": {
    "content_digest": "23fbdfc7ef2187d71fb49829b5160a629fa4bf4837564168349a896fd249f9fe",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests the WATCHMAN device against warfarin",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:watchman",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00129545-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Lists atrial fibrillation as its first condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:atrial-fibrillation",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00129545-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:boston-scientific",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00129545-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Tests left atrial appendage closure",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:left-atrial-appendage-occlusion",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00129545-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/protect-af/",
  "context_path": "api/v1/context/cardio--protect-af.md"
}