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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: WATCHMAN LAAC Device Implant; Drug: Single Antiplatelet Therapy or No Therapy (Control)

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.

• Study Type: Interventional
• Enrollment (Actual): 481
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouw Ziekenhuis
  • Antwerp, Belgium
    • ZNA Middelheim
• Canada
  • Ottawa, Canada
    • Ottawa Heart Institute
  • Ste-foy, Canada
    • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
  • Vancouver, Canada
    • Vancouver General Hospital
• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital
• Denmark
  • Aarhus N, Denmark, DK-8200
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet Copenhagen
• Germany
  • Dusseldorf, Germany
    • Universitaetsklinikum Dusseldorf
  • Erfurt, Germany
    • St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
  • Frankfurt, Germany
    • Cardioangiologisches Centrum Bethanien
  • Hamburg, Germany
    • Cardiologicum Hamburg Praxis Wandsbek
  • Leipzig, Germany
    • Herzzentrum Universität Leipzig
• Italy
  • Massa, Italy
    • Fondazione Toscana Gabriele Monasterio
• Netherlands
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospital
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • London, United Kingdom
    • Guys and St. Thomas NHS Foundation Trust
  • London, United Kingdom
    • The Brompton Hospital
  • Oxford, United Kingdom
    • John Radcliffe Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Arrhythmia Research Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • La Jolla, California, United States, 10666
      • Scripps Memorial Hospital
    • Los Angeles, California, United States, 90048
      • Cedars - Sinai Medical Center
    • San Diego, California, United States, 92121
      • Sharpe Chula Vista Medical Center
    • Santa Barbara, California, United States, 93102
      • Santa Barbara Cottage Hospital
    • Santa Monica, California, United States, 90404
      • St. John's Health Center
  • Colorado
    • Greeley, Colorado, United States, 80631
      • North Colorado Medical Center
    • Lakewood, Colorado, United States, 80228
      • St. Anthony Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Medical Center
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33511
      • Bay Area Cardiology Associates
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Evanston, Illinois, United States, 60201
      • Evanston Hospital
    • Naperville, Illinois, United States, 60540
      • Edward Hospital
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent's Hospital
    • Newburgh, Indiana, United States, 47630
      • Heart Group at Deaconness Hospital
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Mercy Hospital Medical Center
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Cardiac Arrhythmia Research
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Maine
    • Portland, Maine, United States, 04074
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Union Memorial Hospital
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Southcoast Physicians Group
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Foundation
    • Saint Cloud, Minnesota, United States, 56303
      • Centracare Heart and Vascular
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital of Kansas City
    • Saint Louis, Missouri, United States, 63141
      • Mercy Research
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • The Nebraska Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of the Delaware Valley
    • Newark, New Jersey, United States, 07112
      • St. Barnabas Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Staten Island, New York, United States, 10305
      • Northwell Health
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Harrisburg, Pennsylvania, United States, 17043
      • UPMC Heart and Vascular Institute Harrisburg
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S Hershey Medical Center
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas Health
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • The Woodlands, Texas, United States, 77384
      • University of Texas Houston Health Science Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital
  • Washington
    • Tacoma, Washington, United States, 98405
      • CHI Franciscan Health System
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53215
      • Froedtert Memorial Lutheran Hospital
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Heart and Vascular Institute - Research and Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WATCHMAN (Device); WATCHMAN LAAC Device implant including modified post-implant drug regimen.	Device: WATCHMAN LAAC Device Implant; WATCHMAN LAAC Implant
Active Comparator: Control; Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.	Drug: Single Antiplatelet Therapy or No Therapy (Control); Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Endpoint - Major Bleeding	The occurrence of major bleeding (defined as a BARC Type 3 or 5 event)	5 years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Jacqueline Saw, MD, Vancouver General Hospital; Principal Investigator: Maurice Buchbinder, MD, Stanford University; Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimated): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Non-valvular atrial fibrillation; Left atrial appendage
• Other Study ID Numbers: S2317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes