Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)

Boston Scientific

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: WATCHMAN LAA Closure Technology (Gen 4.0)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196897

CT1000

Details and patient eligibility

About

This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
• Eligible for long-term Warfarin therapy;
• Eligible to come off Warfarin therapy if the LAA is sealed
• Calculated CHADS2 score of 1 or greater

Key Exclusion Criteria:

• New York Heart Association Class IV Congestive Heart Failure
• Recent MI (within 3 months)
• ASD and/or atrial septal repair or closure device
• Resting heart rate >110 bpm
• Has an implanted mechanical valve prosthesis
• Left atrial appendage is obliterated
• Has undergone heart transplantation
• Has symptomatic carotid disease
• Contraindicated for aspirin
• LVEF < 30%
• Cardiac Tumor

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Implantable device

Experimental group

Description:

WATCHMAN LAA Closure Technology (Gen 4.0)

Treatment:

Device: WATCHMAN LAA Closure Technology (Gen 4.0)