Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation

Stroke Clinical Trial

— ASAP-TOO  

Official title:

Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02928497
• Other study ID #: S2317
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 481
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• WATCHMAN LAAC Device Implant
WATCHMAN LAAC Implant

Drug:
• Single Antiplatelet Therapy or No Therapy (Control)
Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst
Belgium	ZNA Middelheim	Antwerp
Canada	Ottawa Heart Institute	Ottawa
Canada	Institut universitaire de Cardiologie et de Pneumologie de Quebec	Ste-foy
Canada	Vancouver General Hospital	Vancouver
Czechia	Na Homolce Hospital	Prague
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Rigshospitalet Copenhagen	Copenhagen
Germany	Universitaetsklinikum Dusseldorf	Dusseldorf
Germany	St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH	Erfurt
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt
Germany	Cardiologicum Hamburg Praxis Wandsbek	Hamburg
Germany	Herzzentrum Universität Leipzig	Leipzig
Italy	Fondazione Toscana Gabriele Monasterio	Massa
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Guys and St. Thomas NHS Foundation Trust	London
United Kingdom	The Brompton Hospital	London
United Kingdom	John Radcliffe Hospital	Oxford
United States	Summa Health System	Akron	Ohio
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Emory University Hospital	Atlanta	Georgia
United States	Union Memorial Hospital	Baltimore	Maryland
United States	Billings Clinic	Billings	Montana
United States	Grandview Medical Center	Birmingham	Alabama
United States	Aultman Hospital	Canton	Ohio
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Ohio State University Medical Center	Columbus	Ohio
United States	OhioHealth Research and Innovation Institute - Riverside Methodist Hospital	Columbus	Ohio
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Delray Medical Center	Delray Beach	Florida
United States	Henry Ford Hospital	Detroit	Michigan
United States	Evanston Hospital	Evanston	Illinois
United States	Southcoast Physicians Group	Fall River	Massachusetts
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	North Colorado Medical Center	Greeley	Colorado
United States	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	UPMC Heart and Vascular Institute Harrisburg	Harrisburg	Pennsylvania
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Huntsville Hospital	Huntsville	Alabama
United States	St. Vincent's Hospital	Indianapolis	Indiana
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Scripps Memorial Hospital	La Jolla	California
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	St. Anthony Hospital	Lakewood	Colorado
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Cedars - Sinai Medical Center	Los Angeles	California
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Edward Hospital	Naperville	Illinois
United States	Saint Thomas Health	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	St. Barnabas Medical Center	Newark	New Jersey
United States	Heart Group at Deaconness Hospital	Newburgh	Indiana
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	The Nebraska Medical Center	Omaha	Nebraska
United States	Kansas City Cardiac Arrhythmia Research	Overland Park	Kansas
United States	Arizona Arrhythmia Research Center	Phoenix	Arizona
United States	Maine Medical Center	Portland	Maine
United States	Oregon Health Sciences University	Portland	Oregon
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Mayo Clinic Foundation	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	Centracare Heart and Vascular	Saint Cloud	Minnesota
United States	Mercy Research	Saint Louis	Missouri
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	Sharpe Chula Vista Medical Center	San Diego	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	St. John's Health Center	Santa Monica	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	St. John's Hospital	Springfield	Illinois
United States	Northwell Health	Staten Island	New York
United States	CHI Franciscan Health System	Tacoma	Washington
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Bay Area Cardiology Associates	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	University of Texas Houston Health Science Center	The Woodlands	Texas
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	PeaceHealth Southwest Medical	Vancouver	Washington
United States	Washington Hospital Center	Washington	District of Columbia
United States	Aspirus Heart and Vascular Institute - Research and Education	Wausau	Wisconsin
United States	Mercy Hospital Medical Center	West Des Moines	Iowa
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Denmark,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary 7-Day Device/Procedural Safety Endpoint	The primary safety endpoint is the 7-day combined rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.	7 days
Primary	Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism.	The primary efficacy endpoint is the comparison of time to first event of ischemic stroke and systemic embolism.	5 years
Secondary	Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death	The occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular death (cardiovascular and/or unexplained cause) and systemic embolism	5 years
Secondary	Secondary Endpoint - Major Bleeding	The occurrence of major bleeding (defined as a BARC Type 3 or 5 event)	5 years