NCT00129545

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

Study Contact:

Study Phase:

PHASE2

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00129545

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

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.

Eligibility

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)
* Congestive heart failure (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%

Disease(s) and\or Condition(s)

Atrial Fibrillation

Stroke

Primary Purpose

PREVENTION

Intervention/Treatment

- Type: DEVICE
- Name: WATCHMAN Left Atrial Appendage Closure Technology
- Description: Implant of WATCHMAN Left Atrial Appendage Closure Technology
- Arm Group Labels: Roll-in, WATCHMAN
- Type: DRUG
- Name: Warfarin
- Description: Subjects receive warfarin
- Arm Group Labels: Warfarin control

Sponsor

Boston Scientific Corporation