ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology

NCT ID: NCT00851578

Last Updated: 2015-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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WATCHMAN

non-valvular atrial fibrillation patients contraindicated to warfarin

Group Type EXPERIMENTAL

WATCHMAN

Intervention Type DEVICE

WATCHMAN LAA Closure Device

Interventions

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WATCHMAN

WATCHMAN LAA Closure Device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vivek Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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NA Homolce Hospital

Prague, , Czechia

Site Status

Sankt Katharinen Hospital / Cardiovasculares Centrum

Frankfurt, , Germany

Site Status

Herzzentrum Leipzig

Leipzig, , Germany

Site Status

Chefarzt der Medizinischen Klinik III/Kardiologie

Regensburg, , Germany

Site Status

Countries

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Czechia Germany

References

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Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.

Reference Type DERIVED
PMID: 23583249 (View on PubMed)

Other Identifiers

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ST1056

Identifier Type: -

Identifier Source: org_study_id

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