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

This study is currently recruiting participants.
Verified March 2017 by Boston Scientific Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02928497
First Posted: October 10, 2016
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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.

Condition Intervention
Stroke Device: WATCHMAN LAAC Implant Drug: Single Antiplatelet Therapy of No Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Primary 7-Day Device/Procedural Safety Endpoint [ Time Frame: 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. [ Time Frame: 5 years ]
    The primary efficacy endpoint is the comparison of time to first event of ischemic stroke and systemic embolism.


Secondary Outcome Measures:
  • Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death [ Time Frame: 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 [ Time Frame: 5 years ]
    The occurrence of major bleeding (defined as a BARC Type 3 or 5 event)


Estimated Enrollment: 888
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WATCHMAN (Device)
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
Device: WATCHMAN LAAC Implant
WATCHMAN LAAC Implant
Active Comparator: Single antiplatelet therapy (Control)
Single antiplatelet therapy or no therapy at the discretion of the study physician for the duration of the trial.
Drug: Single Antiplatelet Therapy of No Therapy
Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928497


Contacts
Contact: Myriah Elletson 1-800-CARDIAC myriah.elletson@bsci.com
Contact: Jennifer Williams 1-800-CARDIAC jennifer.williams2@bsci.com

Locations
United States, Alabama
Grandview Medical Center Recruiting
Birmingham, Alabama, United States, 35243
Contact: Susan Thorington, RN       sthorington@alcardio.com   
Principal Investigator: Jose Osorio, MD         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Shine Kim       shine.y.kim@medstar.net   
Principal Investigator: Manish Shah, MD         
United States, Florida
Lakeland Regional Medical Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Adrienne Haines-Adams       ahaines-adams@watsonclinic.com   
Principal Investigator: Neal Kavesh, MD         
Tallahassee Memorial Hospital Recruiting
Tallahassee, Florida, United States, 32308
Contact: Patty Knap       Patty.Knap@tmh.org   
Principal Investigator: Farhat Khairallah, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Paige Smith       pfsmith@emory.edu   
Principal Investigator: David DeLurgio, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Kristie Schneider       kschneid@bhsi.com   
Principal Investigator: Gery Tomassoni, MD         
United States, Maryland
Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Contact: Rachel Campbell       rachel.e.campbell@medstar.net   
Principal Investigator: John Wang, MD         
United States, Minnesota
Mayo Clinic Foundation Recruiting
Rochester, Minnesota, United States, 55905
Contact: Pamela Mundt       mundt.pamela@mayo.edu   
Principal Investigator: David Holmes, MD         
HealthEast St. Joseph's Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Beth Jorgenson       bjorgenson@healtheast.org   
Principal Investigator: Stuart Adler, MD         
United States, Mississippi
North Mississippi Medical Center Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Kristin Eads, RN       keads@nmhs.net   
Principal Investigator: James Stone, Jr., MD         
United States, New Hampshire
Catholic Medical Center Recruiting
Manchester, New Hampshire, United States, 03102
Contact: Elizabeth Corrnelius       elizabeth.cornelius@cmc-nh.org   
Principal Investigator: Jamie Kim, MD         
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Lance Glickman       lance.glickman@mountsinai.org   
Principal Investigator: Srinivas Kukkipati, MD         
Columbia University Medical Center/NewYork Presbyterian Hospital Not yet recruiting
New York, New York, United States, 10032
Contact: Kate Dalton       keb2114@columbia.edu   
Principal Investigator: Robert Sommer, MD         
United States, Pennsylvania
York Hospital Recruiting
York, Pennsylvania, United States, 17403
Contact: Sarah Lake       slake@wellspan.org   
Principal Investigator: James Harvey, MD         
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes       lgs2m@hscmail.mcc.virginia.edu   
Principal Investigator: Rohit Malhotra, MD         
Sentara Norfolk General Hospital Not yet recruiting
Norfolk, Virginia, United States, 23507
Contact: Brittany McMichael       bymcmich@sentara.com   
Principal Investigator: Paul Mahoney, MD         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Gina Behr       gina.behr@aurora.org   
Principal Investigator: Jasbir Sra, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Jacqueline Saw, MD Vancouver General Hospital
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Maurice Buchbinder, MD Stanford University
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02928497     History of Changes
Other Study ID Numbers: S2317
First Submitted: October 5, 2016
First Posted: October 10, 2016
Last Update Posted: June 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Boston Scientific Corporation:
Non-valvular atrial fibrillation
Left atrial appendage