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

Completed · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT02928497

Run by

Boston Scientific Corporation

People needed

481

Starts

2017-02-06

Expected to finish

2025-09-23

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Huntsville Hospital — Huntsville, Alabama, United States
• Arizona Arrhythmia Research Center — Phoenix, Arizona, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Scripps Memorial Hospital — La Jolla, California, United States
• Cedars - Sinai Medical Center — Los Angeles, California, 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
• North Colorado Medical Center — Greeley, Colorado, United States
• St. Anthony Hospital — Lakewood, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Lakeland Regional Medical Center — Lakeland, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Bay Area Cardiology Associates — Tampa, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Evanston Hospital — Evanston, Illinois, United States
• Edward Hospital — Naperville, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• St. John's Hospital — Springfield, Illinois, United States
• St. Vincent's Hospital — Indianapolis, Indiana, United States
• Grandview Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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