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

January 26, 2015 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 150 30
        • Na Homolce Hospital
  • Germany
      • Frankfurt, Germany, 60389
        • Sankt Katharinen Hospital / Cardiovasculares Centrum
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig
      • Regensburg, Germany, 93049
        • Chefarzt der Medizinischen Klinik III/Kardiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WATCHMAN
non-valvular atrial fibrillation patients contraindicated to warfarin
Device: WATCHMAN
WATCHMAN LAA Closure Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST1056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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