ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology (ASAP)
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ClinicalTrials.gov Identifier: NCT00851578 |
Recruitment Status
:
Completed
First Posted
: February 26, 2009
Last Update Posted
: January 27, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation | Device: WATCHMAN | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: WATCHMAN
non-valvular atrial fibrillation patients contraindicated to warfarin
|
Device: WATCHMAN
WATCHMAN LAA Closure Device
|
- Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851578
Czech Republic | |
NA Homolce Hospital | |
Prague, Czech Republic, 150 30 | |
Germany | |
Sankt Katharinen Hospital / Cardiovasculares Centrum | |
Frankfurt, Germany, 60389 | |
Herzzentrum Leipzig | |
Leipzig, Germany, 04289 | |
Chefarzt der Medizinischen Klinik III/Kardiologie | |
Regensburg, Germany, 93049 |
Principal Investigator: | Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00851578 History of Changes |
Other Study ID Numbers: |
ST1056 |
First Posted: | February 26, 2009 Key Record Dates |
Last Update Posted: | January 27, 2015 |
Last Verified: | September 2013 |
Keywords provided by Boston Scientific Corporation:
AF atrial fibrillation LAA occlusion |
Additional relevant MeSH terms:
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |