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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 : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Device: WATCHMAN LAAC Device Implant Drug: Single Antiplatelet Therapy or No Therapy (Control) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 481 participants
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)
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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

  2. Secondary Endpoint - Major Bleeding [ Time Frame: 5 years ]
    The occurrence of major bleeding (defined as a BARC Type 3 or 5 event)


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02928497    
Other Study ID Numbers: S2317
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Boston Scientific Corporation:
Non-valvular atrial fibrillation
Left atrial appendage