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

Boston Scientific

Status and phase: Completed; Phase 3; Phase 2

Conditions: Atrial Fibrillation; Stroke

Treatments: Drug: Warfarin; Device: WATCHMAN Left Atrial Appendage Closure Technology

Study type: Interventional

Funder types: Industry

Identifiers

NCT00129545

ST1021 and ST1055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

800 participants in 3 patient groups

WATCHMAN

Experimental group

Description:

Implant of WATCHMAN Left Atrial Appendage Closure Technology

Treatment:

Device: WATCHMAN Left Atrial Appendage Closure Technology

Warfarin control

Active Comparator group

Description:

Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin

Treatment:

Drug: Warfarin

Roll-in

Other group

Description:

Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.

Treatment:

Device: WATCHMAN Left Atrial Appendage Closure Technology