Overview

This trial is active, not recruiting.

Conditions atrial fibrillation, stroke
Treatment watchman left atrial appendage closure technology
Phase phase 2/phase 3
Sponsor Boston Scientific Corporation
Start date February 2005
End date August 2013
Trial size 1550 participants
Trial identifier NCT00129545, ST1021 and ST1055

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Implantable WATCHMAN Left ATrial Appendage Occlusion Device
watchman left atrial appendage closure technology WATCHMAN
Implant of WATCHMAN Left Atrial Appendage Closure Technology

Primary Outcomes

Measure
All stroke
time frame: 5 years
Systemic embolism
time frame: 5 years
Cardiovascular death
time frame: 5 years

Secondary Outcomes

Measure
Technical success
time frame: 45 days
Procedure success
time frame: 45 days
30 day major adverse event (MAE)
time frame: 30 days
Left atrial appendage (LAA) coverage
time frame: 45 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF) - Eligible for long term warfarin - CHADS score >= 1 (congestive heart failure [CHF], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack [TIA]) Exclusion Criteria: - Contraindicated for warfarin - Contraindicated for aspirin or clopidogrel (Plavix) - CHF Class 4 - Implanted mechanical valve - Atrial septal or Patent Foramen Ovale (PFO) device - Platelets < 100,000 or hemoglobin < 10 - Left ventricular ejection fraction (LVEF) < 30%

Additional Information

Official title WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)
Principal investigator David Holmes, MD
Description The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.