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WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

NCT00129545 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2015-05-15

Study results available
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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.

Conditions

Interventions

DEVICE

WATCHMAN Left Atrial Appendage Closure Technology

Implant of WATCHMAN Left Atrial Appendage Closure Technology

DRUG

Warfarin

Subjects receive warfarin

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • David Holmes, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2013-08-31
Completion
2014-05-31

Countries

  • United States
  • Czechia
  • Germany

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 NCT00129545 on ClinicalTrials.gov