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Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation

NCT02928497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

Conditions

Interventions

DEVICE

WATCHMAN LAAC Device Implant

WATCHMAN LAAC Implant

DRUG

Single Antiplatelet Therapy or No Therapy (Control)

Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Jacqueline Saw, MD · Vancouver General Hospital

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

  • Maurice Buchbinder, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2025-09-23
Completion
2025-09-23
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

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 NCT02928497 on ClinicalTrials.gov