Cardiovascular Atlas
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PROTECT AF

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.

Also called WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

  • Study
  • In this atlas

Overview

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).
Phase
Phase 2/3
Enrolled
  • 800 participants (enrolled count) (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF), retrieved )
  • 707 patients (randomized count) (Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT00129545
Started
(WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF), retrieved )
Primary completion
(actual) (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF), retrieved )
Completion
(actual) (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF), retrieved )
Results first posted
(WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF), retrieved )
Countries
United States, Czechia, Germany (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

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., Lancet 2009;374(9689):534-42 (abstract read only). 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 (Lancet 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.

Arms

  • WATCHMAN

    Intervention WATCHMAN left atrial appendage closure device

    Percutaneous closure of the left atrial appendage with the device and subsequent discontinuation of warfarin (abstract), 463 patients.

  • Warfarin control

    Intervention None named

    Warfarin with a target international normalised ratio between 2.0 and 3.0 (abstract), 244 patients. No separate entity is recorded for warfarin.

  • Roll-in

    Intervention None named

    Device implant in non-randomized subjects, up to three per site, who were not included in the primary analysis (registry).

Findings

No findings are published for this study.

Record details

Record id
cardio:protect-af
Content hash
014078db4e02a5a6652328c01e14ba8c5cf6ab9a6dd5f7ac0e61e0bba167e822