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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
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: WATCHMAN Not Applicable

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: WATCHMAN
non-valvular atrial fibrillation patients contraindicated to warfarin
 Device: WATCHMAN
WATCHMAN LAA Closure Device


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment [ Time Frame: 2 years ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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