Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
- Conditions
- Stroke
- Interventions
- Drug: Single Antiplatelet Therapy or No Therapy (Control)Device: WATCHMAN LAAC Device Implant
- Registration Number
- NCT02928497
- Lead Sponsor
- Boston Scientific Corporation
- Brief 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.
- Detailed Description
The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke.
Subjects will be randomized in a ratio of 2 Device to 1 Control to receive the WATCHMAN LAA closure device (Device) or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician (Control). All randomized subjects will follow the protocol required tests and assessments at each scheduled follow-up visit.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 481
- 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.
- The subject is unable or unwilling to return for required follow-up visits and examinations.
- The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
- The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
- The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.
- The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
- The subject has a history of atrial septal repair or has an ASD/PFO device.
- The subject has an implanted mechanical valve prosthesis in any position.
- The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
- The subject has LVEF < 30%.
- The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
- The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
- The subject has a life expectancy of less than two years.
- The subject has a known or suspected hypercoagulable state.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Single Antiplatelet Therapy or No Therapy (Control) Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial. WATCHMAN (Device) WATCHMAN LAAC Device Implant WATCHMAN LAAC Device implant including modified post-implant drug regimen.
- Primary Outcome Measures
Name Time Method Primary 7-Day Device/Procedural Safety Endpoint 7 days The primary safety endpoint is the 7-day combined rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.
Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism. 5 years The primary efficacy endpoint is the comparison of time to first event of ischemic stroke and systemic embolism.
- Secondary Outcome Measures
Name Time Method Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death 5 years The occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular death (cardiovascular and/or unexplained cause) and systemic embolism
Secondary Endpoint - Major Bleeding 5 years The occurrence of major bleeding (defined as a BARC Type 3 or 5 event)
Trial Locations
- Locations (92)
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Cedars - Sinai Medical Center
🇺🇸Los Angeles, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Sharpe Chula Vista Medical Center
🇺🇸San Diego, California, United States
Kansas City Cardiac Arrhythmia Research
🇺🇸Overland Park, Kansas, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Arizona Arrhythmia Research Center
🇺🇸Phoenix, Arizona, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Mayo Clinic Foundation
🇺🇸Rochester, Minnesota, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Mercy Research
🇺🇸Saint Louis, Missouri, United States
Bay Area Cardiology Associates
🇺🇸Tampa, Florida, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
St. John's Health Center
🇺🇸Santa Monica, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
St. Anthony Hospital
🇺🇸Lakewood, Colorado, United States
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
Edward Hospital
🇺🇸Naperville, Illinois, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
St. Vincent's Hospital
🇺🇸Indianapolis, Indiana, United States
Mercy Hospital Medical Center
🇺🇸West Des Moines, Iowa, United States
Heart Group at Deaconness Hospital
🇺🇸Newburgh, Indiana, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Southcoast Physicians Group
🇺🇸Fall River, Massachusetts, United States
HealthEast St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Centracare Heart and Vascular
🇺🇸Saint Cloud, Minnesota, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
St. Barnabas Medical Center
🇺🇸Newark, New Jersey, United States
Northwell Health
🇺🇸Staten Island, New York, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
UPMC Heart and Vascular Institute Harrisburg
🇺🇸Harrisburg, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
University of Texas Houston Health Science Center
🇺🇸The Woodlands, Texas, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Carilion Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States
CHI Franciscan Health System
🇺🇸Tacoma, Washington, United States
Aspirus Heart and Vascular Institute - Research and Education
🇺🇸Wausau, Wisconsin, United States
PeaceHealth Southwest Medical
🇺🇸Vancouver, Washington, United States
ZNA Middelheim
🇧🇪Antwerp, Belgium
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aalst, Belgium
Institut universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Ste-foy, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Canada
Vancouver General Hospital
🇨🇦Vancouver, Canada
Na Homolce Hospital
🇨🇿Prague, Czechia
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Universitaetsklinikum Dusseldorf
🇩🇪Dusseldorf, Germany
Rigshospitalet Copenhagen
🇩🇰Copenhagen, Denmark
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
🇩🇪Erfurt, Germany
Cardiologicum Hamburg Praxis Wandsbek
🇩🇪Hamburg, Germany
Cardioangiologisches Centrum Bethanien
🇩🇪Frankfurt, Germany
Fondazione Toscana Gabriele Monasterio
🇮🇹Massa, Italy
Herzzentrum Universität Leipzig
🇩🇪Leipzig, Germany
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Guys and St. Thomas NHS Foundation Trust
🇬🇧London, United Kingdom
The Brompton Hospital
🇬🇧London, United Kingdom
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Saint Thomas Health
🇺🇸Nashville, Tennessee, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
St. Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States