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ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology (ASAP)
This study has been completed.
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00851578
First received: February 24, 2009
Last updated: January 26, 2015
Last verified: September 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
| Atrial Fibrillation | Device: WATCHMAN |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment [ Time Frame: 2 years ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2009 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: WATCHMAN
non-valvular atrial fibrillation patients contraindicated to warfarin
|
Device: WATCHMAN
WATCHMAN LAA Closure Device
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851578
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851578
Locations
| 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 | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Principal Investigator: | Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai |
More Information
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 |
| Study First Received: | February 24, 2009 |
| Last Updated: | January 26, 2015 |
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 |
ClinicalTrials.gov processed this record on June 28, 2017