CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 800 enrolled
Drug / intervention
Warfarin +1 moredrug
Likely dose
WATCHMAN Left Atrial Appendage Closure Device implantationAI-extracted
Key inclusion· 3
  • ✓Non-valvular atrial fibrillation (paroxysmal, persistent, or permanent)
  • ✓Eligible for long-term warfarin therapy
  • ✓CHADS score ≥1 (at least one stroke risk factor present)
Key exclusion· 7
  • ✕Contraindicated for warfarin
  • ✕Contraindicated for aspirin or clopidogrel
  • ✕Congestive heart failure (CHF) Class 4
  • ✕Implanted mechanical valve

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00129545
NCT00129545Phase 3Completed
CompareCT.gov

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

Boston Scientific Corporation·interventional·Posted Aug 12, 2005·Updated May 15, 2015

In Brief

A Phase 3 clinical trial evaluating WATCHMAN Left Atrial Appendage Closure Technology and Warfarin for Atrial Fibrillation and Stroke. Completed, enrolled 800 participants across 62 sites in 3 countries.

Detailed Summary

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Stroke
CountriesCzechia, Germany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 12, 2005
Enrollment StartFeb 1, 2005
Primary CompletionAug 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 20.9 years ago

Interventions

WATCHMAN Left Atrial Appendage Closure Technologydevice

Implant of WATCHMAN Left Atrial Appendage Closure Technology

Warfarindrug

Subjects receive warfarin