Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
Status: Active_not_recruiting
Location: See all (91) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• The subject is of legal age to participate in the study per the laws of their respective geography.
• The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).
• The subject has a calculated CHA2DS2-VASc score of 2 or greater.
• The subject is deemed by two study physicians to be unsuitable for oral anticoagulation.
• The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
• The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
• The subject is able and willing to return for required follow-up visits and examinations.
Locations
United States
Alabama
Grandview Medical Center
Birmingham
Huntsville Hospital
Huntsville
Arkansas
Arrhythmia Research Group
Jonesboro
Arizona
Arizona Arrhythmia Research Center
Phoenix
California
Scripps Memorial Hospital
La Jolla
Cedars - Sinai Medical Center
Los Angeles
Sharpe Chula Vista Medical Center
San Diego
Santa Barbara Cottage Hospital
Santa Barbara
St. John's Health Center
Santa Monica
Colorado
North Colorado Medical Center
Greeley
St. Anthony Hospital
Lakewood
Washington, D.c.
Washington Hospital Center
Washington
Florida
Delray Medical Center
Delray Beach
Lakeland Regional Medical Center
Lakeland
Sarasota Memorial Hospital
Sarasota
Tallahassee Memorial Hospital
Tallahassee
Bay Area Cardiology Associates
Tampa
Tampa General Hospital
Tampa
Georgia
Emory University Hospital
Atlanta
Iowa
Mercy Hospital Medical Center
West Des Moines
Illinois
Northwestern Memorial Hospital
Chicago
Evanston Hospital
Evanston
Edward Hospital
Naperville
Advocate Christ Medical Center
Oak Lawn
St. John's Hospital
Springfield
Indiana
St. Vincent's Hospital
Indianapolis
Heart Group at Deaconness Hospital
Newburgh
Kansas
Kansas City Cardiac Arrhythmia Research
Overland Park
Kentucky
Baptist Health Lexington
Lexington
Massachusetts
Southcoast Physicians Group
Fall River
Maryland
Union Memorial Hospital
Baltimore
Maine
Maine Medical Center
Portland
Michigan
Henry Ford Hospital
Detroit
Minnesota
Mayo Clinic Foundation
Rochester
Centracare Heart and Vascular
Saint Cloud
HealthEast St. Joseph's Hospital
Saint Paul
Missouri
St. Luke's Hospital of Kansas City
Kansas City
Mercy Research
Saint Louis
Mississippi
North Mississippi Medical Center
Tupelo
Montana
Billings Clinic
Billings
North Carolina
Carolinas Medical Center
Charlotte
Nebraska
The Nebraska Medical Center
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
Catholic Medical Center
Manchester
New Jersey
Cardiovascular Associates of the Delaware Valley
Haddon Heights
St. Barnabas Medical Center
Newark
The Valley Hospital
Ridgewood
New York
Mount Sinai Medical Center
New York
Rochester General Hospital
Rochester
Northwell Health
Staten Island
Ohio
Summa Health System
Akron
Aultman Hospital
Canton
Ohio State University Medical Center
Columbus
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus
Oklahoma
Oklahoma Heart Institute
Tulsa
Oregon
Oregon Health Sciences University
Portland
Pennsylvania
Lehigh Valley Hospital
Allentown
UPMC Heart and Vascular Institute Harrisburg
Harrisburg
Penn State Milton S Hershey Medical Center
Hershey
York Hospital
York
Tennessee
Saint Thomas Health
Nashville
Texas
Baylor Heart and Vascular Hospital
Dallas
University of Texas Houston Health Science Center
The Woodlands
Virginia
University of Virginia Medical Center
Charlottesville
Inova Fairfax Hospital
Falls Church
Carilion Roanoke Memorial Hospital
Roanoke
Washington
CHI Franciscan Health System
Tacoma
PeaceHealth Southwest Medical
Vancouver
Wisconsin
Aurora St. Luke's Medical Center
Milwaukee
Froedtert Memorial Lutheran Hospital
Milwaukee
Aspirus Heart and Vascular Institute - Research and Education
Wausau
Other Locations
Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst
ZNA Middelheim
Antwerp
Canada
Ottawa Heart Institute
Ottawa
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste-foy
Vancouver General Hospital
Vancouver
Denmark
Aarhus University Hospital
Aarhus N
Rigshospitalet Copenhagen
Copenhagen
Germany
Universitaetsklinikum Dusseldorf
Dusseldorf
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
Erfurt
Cardioangiologisches Centrum Bethanien
Frankfurt
Cardiologicum Hamburg Praxis Wandsbek
Hamburg
Herzzentrum Universität Leipzig
Leipzig
Italy
Fondazione Toscana Gabriele Monasterio
Massa
Netherlands
Medisch Spectrum Twente
Enschede
St. Antonius Ziekenhuis
Nieuwegein
United Kingdom
Royal Victoria Hospital
Belfast
Royal Sussex County Hospital
Brighton
Guys and St. Thomas NHS Foundation Trust
London
The Brompton Hospital
London
John Radcliffe Hospital
Oxford
Time Frame
Start Date: 2017-02-06
Completion Date: 2025-12
Participants
Target number of participants: 481
Treatments
Experimental: WATCHMAN (Device)
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
Active_comparator: Control
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
Authors
Robert Pickett, Robert Eckart, Farhat Khairallah, Gery Tomassoni, Jeremiah Depta, Loren Budge, German Larrain, David Zhao, Umesh Gowda, Robert Piana, Andrew Corsello, Marcie Berger, Paul Mahoney, Brijeshwar Maini, Mahesh Mulumudi, Claudio Schuger, Shephal Doshi, James Stone Jr, Robert Fishel, Raul Weiss, James Harvey, James Kleman, Moustapha Atoui, Yoaav Krauthammer, Chandrashekar Kumbar, Suneet Mittal, Jasbir Sra, Jose Nazari, Megan Coylewright, Babak Bozorgnia, Dennis Cooke, Jeffrey Chambers, Ziad Issa, Stuart Adler, James Choi, Neal Kavesh, Jamie Kim, Jeffery Allison, Gunjan Shukla, Vijendra Swarup, Shane Rowan, Troy Hounshell, Ashish Pershad, Bengt Herweg, Joseph Germano, David Dobesh, Maurice Buchbinder, Saibal Kar, Bradley Knight, Kenneth Huber, Ted Feldman, Sarah Hussain, Jason Foerst, Moeen Saleem, Michael Shehata, Matthew Sherwood, Hemal Gada, Rohit Malhotra, Eathar Razak, Saumya Sharma, Timothy LessMeier, Manoj Duggal, Marc Lahiri, Anthony Sonn, Anwar Tandar, Robert Sommer, Henning Ebelt, Marcus Sandri, Volker Schulze, Martin Bergmann, Scott Sample, Pradeep Yadav, Sandeep Goyal, Marcin Kowalski, Srinivas Dukkipati, Ganesh Venkataraman, Michael Kim, Devi Nair, Apoor Patel, Brian Clapp, Marcoen Scholten, Adam Sukiennik, Tim Betts, Paul Vermeersch, Muzahir Tayebjee, Adel Aminian, Gilles O'Hara, Tom Wong, Sergio Berti, Carlos Morillo, Lucas Boersma, Tom De Potter, Jacqueline Saw, David Hildick-Smith, Yuri Blaauw, Lars Soendergaard, Patrizio Lancellotti, Petr Neuzil
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation