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WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

NCT03173534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-05-22

Study results available
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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).

Conditions

Interventions

DEVICE

WATCHMAN

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.

DEVICE

TAVR

Transcatheter Aortic Valve Replacement

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • The Cleveland Clinic

    collaborator OTHER

  • samir kapadia

    lead OTHER

Principal Investigators

  • Samir Kapadia, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2022-12-06
Completion
2022-12-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03173534 on ClinicalTrials.gov