Status:
COMPLETED
ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- NYHA Class IV
- LAA obliteration
- Heart transplant
- LVEF less than 30%
- greater than 50% carotid stenosis
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00851578
Start Date
January 1 2009
End Date
December 1 2013
Last Update
January 27 2015
Active Locations (4)
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1
NA Homolce Hospital
Prague, Czechia, 150 30
2
Sankt Katharinen Hospital / Cardiovasculares Centrum
Frankfurt, Germany, 60389
3
Herzzentrum Leipzig
Leipzig, Germany, 04289
4
Chefarzt der Medizinischen Klinik III/Kardiologie
Regensburg, Germany, 93049