Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation; Stroke

Treatments: Device: WATCHMAN Device; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01182441

CT1004

Details and patient eligibility

About

This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Paroxysmal, persistent or permanent non-valvular AF

• Eligible for long-term warfarin therapy

• Eligible to come off warfarin therapy

• Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:

  • Female age 75 or older
  • Baseline LVEF ≥ 30 and < 35%
  • Aged 65-74 and has diabetes or coronary artery disease
  • Aged 65 or greater and has congestive heart failure

Key Exclusion Criteria:

• Contraindicated/allergic to aspirin
• Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
• History of atrial septal repair or has an ASD/PFO device
• Implanted mechanical valve prosthesis
• NYHA Class IV CHF
• Resting heart rate > 110 bpm
• Participated previously in the PROTECT AF or CAP Registry studies

Key Echo Exclusion Criteria:

• LVEF < 30%
• Existing pericardial effusion > 2mm
• High risk PFO
• Significant mitral valve stenosis
• Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
• Cardiac tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

407 participants in 2 patient groups

WATCHMAN

Experimental group

Description:

Subjects assigned to receive the WATCHMAN device.

Treatment:

Device: WATCHMAN Device

Warfarin

Active Comparator group

Description:

Subjects assigned to warfarin therapy.

Treatment:

Drug: Warfarin