ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology (ASAP)

Boston Scientific

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: WATCHMAN

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851578

ST1056

Details and patient eligibility

About

The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• paroxysma, persistent, or permanent non-vlavular atrial fibrillation
• contraindicated to warfarin
• eligible for clopidogrel, ticlopdine, heparin, or aspirin
• CHADS score 1 or greater

Exclusion criteria

• NYHA Class IV
• LAA obliteration
• Heart transplant
• LVEF less than 30%
• greater than 50% carotid stenosis

Trial design

150 participants in 1 patient group

WATCHMAN

Experimental group

Description:

non-valvular atrial fibrillation patients contraindicated to warfarin

Treatment:

Device: WATCHMAN