ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology - Full Text View

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

This study is currently recruiting participants.

Verified June 2011 by Atritech

First Received on February 24, 2009. Last Updated on June 6, 2011 History of Changes

Sponsor:	Atritech
Information provided by:	Atritech
ClinicalTrials.gov Identifier:	NCT00851578

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:	Allocation: Non-Randomized 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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

U.S. FDA Resources

Further study details as provided by Atritech:

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
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	January 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851578

Locations

Czech Republic
NA Homolce Hospital	Recruiting
Prague, Czech Republic, 150 30
Contact: Michal Bejr 00420 257273301 Michal.Bejr@homolka.cz
Principal Investigator: Petr Neuzil, MD
Germany
Sankt Katharinen Hospital / Cardiovasculares Centrum	Recruiting
Frankfurt, Germany, 60389
Contact: Annkatharin Braut 004906946031358 annkathrin.braut@gmx.de
Principal Investigator: Horst Seivert, MD
Herzzentrum Leipzig	Recruiting
Leipzig, Germany, 04289
Contact: Carola Doehnert doec@server3.medizin.uni-leipzig.de
Principal Investigator: Sven Mobius-Winkler
Chefarzt der Medizinischen Klinik III/Kardiologie	Recruiting
Regensburg, Germany, 93049
Contact: Sonja Lausser 941 369 2119 Sonja.Lausser@barmherzige-regensburg.de
Principal Investigator: Peter Sick, MD

Sponsors and Collaborators

Atritech

Investigators

Principal Investigator:

Vivek Reddy, MD

Mount Sinai School of Medicine

More Information

No publications provided

Responsible Party:	Vivek Reddy, MD, Mount Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00851578 History of Changes
Other Study ID Numbers:	ST1056
Study First Received:	February 24, 2009
Last Updated:	June 6, 2011
Health Authority:	Germany: Ethics Commission

Keywords provided by Atritech:

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 May 23, 2012