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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928497
Recruitment Status : Active, not recruiting
First Posted : October 10, 2016
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE October 5, 2016
First Posted Date  ICMJE October 10, 2016
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
  • The occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular death (cardiovascular and/or unexplained cause) and systemic embolism [ Time Frame: 5 years ]
  • The occurrence of major bleeding (defined as a BARC Type 3 or 5 event) [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
Official Title  ICMJE Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: WATCHMAN (Device)
    WATCHMAN LAAC Device implant including modified post-implant drug regimen.
    Intervention: Device: WATCHMAN LAAC Device Implant
  • Active Comparator: Control
    Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
    Intervention: Drug: Single Antiplatelet Therapy or No Therapy (Control)
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2016)
888
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Denmark,   Germany,   Italy,   Netherlands,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02928497
Other Study ID Numbers  ICMJE S2317
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Boston Scientific Corporation
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP