CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 350 enrolled
Drug / intervention
WATCHMAN +1 moredevice
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/NCT03173534
NCT03173534N/ACompleted
CompareCT.gov

WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

samir kapadia·interventional·Posted Jun 2, 2017·Updated May 22, 2024

In Brief

A clinical study evaluating WATCHMAN and TAVR for Atrial Fibrillation and Aortic Valve Stenosis. Completed, enrolled 350 participants across 32 sites.

Detailed Summary

To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Aortic Valve Stenosis
CountriesUnited States
CollaboratorsBoston Scientific Corporation, The Cleveland Clinic

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 2, 2017
Enrollment StartDec 15, 2017
Primary CompletionDec 6, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 9.1 years ago

Interventions

WATCHMANdevice

WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.

TAVRdevice

Transcatheter Aortic Valve Replacement