Clinical trial NCT02928497: Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
Official title: Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Non-valvular atrial fibrillation
Left atrial appendage
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-10
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary 7-Day Device/Procedural Safety Endpoint
timeFrame: 7 days
measure: Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism.
timeFrame: 5 years
Secondary outcomes:
measure: Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death
timeFrame: 5 years
measure: Secondary Endpoint - Major Bleeding
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars - Sinai Medical Center
state: California
city: San Diego
country: United States
facility: Sharpe Chula Vista Medical Center
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Santa Monica
country: United States
facility: St. John's Health Center
state: California
city: Greeley
country: United States
facility: North Colorado Medical Center
state: Colorado
city: Lakewood
country: United States
facility: St. Anthony Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Bay Area Cardiology Associates
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Newburgh
country: United States
facility: Heart Group at Deaconness Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Fall River
country: United States
facility: Southcoast Physicians Group
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Foundation
state: Minnesota
city: Saint Cloud
country: United States
facility: Centracare Heart and Vascular
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Research
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Omaha
country: United States
facility: The Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Newark
country: United States
facility: St. Barnabas Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Staten Island
country: United States
facility: Northwell Health
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Heart and Vascular Institute Harrisburg
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: The Woodlands
country: United States
facility: University of Texas Houston Health Science Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Tacoma
country: United States
facility: CHI Franciscan Health System
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Heart and Vascular Institute - Research and Education
state: Wisconsin
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
city: Ste-foy
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec
city: Vancouver
country: Canada
facility: Vancouver General Hospital
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Dusseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Erfurt
country: Germany
facility: St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg Praxis Wandsbek
city: Leipzig
country: Germany
facility: Herzzentrum Universität Leipzig
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: London
country: United Kingdom
facility: Guys and St. Thomas NHS Foundation Trust
city: London
country: United Kingdom
facility: The Brompton Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Vancouver General Hospital
name: Jacqueline Saw, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Maurice Buchbinder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alomar M, Fradley MG. Electrophysiology Translational Considerations in Cardio-Oncology: QT and Beyond. J Cardiovasc Transl Res. 2020 Jun;13(3):390-401. doi: 10.1007/s12265-019-09924-y. Epub 2019 Oct 31.