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ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology (ASAP)

This study has been completed.
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:   Both
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

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
Health Authority: Germany: Ethics Commission

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 September 29, 2016