ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
Not Applicable
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Device: WATCHMAN
- Registration Number
- NCT00851578
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WATCHMAN WATCHMAN non-valvular atrial fibrillation patients contraindicated to warfarin
- Primary Outcome Measures
Name Time Method Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Sankt Katharinen Hospital / Cardiovasculares Centrum
🇩🇪Frankfurt, Germany
NA Homolce Hospital
🇨🇿Prague, Czech Republic
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
Chefarzt der Medizinischen Klinik III/Kardiologie
🇩🇪Regensburg, Germany