CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 407 enrolled
Drug / intervention
Warfarin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01182441
NCT01182441Phase 3Completed
CompareCT.gov

Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy

Boston Scientific Corporation·interventional·Posted Aug 16, 2010·Updated Jul 26, 2018

In Brief

A Phase 3 clinical trial evaluating WATCHMAN Device and Warfarin for Atrial Fibrillation and Stroke. Completed, enrolled 407 participants across 41 sites.

Detailed Summary

This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Stroke
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2010
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2013
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.9 years ago

Interventions

WATCHMAN Devicedevice

WATCHMAN Left Atrial Appendage Closure Technology

Warfarindrug

Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0