Trial for patients with Atrial fibrillation that cannot take anti-coagulants

Trial ID:
IRB-17-6969
Matthew J Price, M.D.
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.

Inclusion Criteria

Patients must:

  • Have documented paroxysmal, persistent, permanent or longterm persistent non-valvular atrial fibrillation
    Be deemed by two study physicians to be unsuitable for oral anticoagulation therapy
    Meet all other eligibility criteria

Exclusion Criteria

Patients must not:

  • Have been diagnosed with rheumatic mitral valvular heart disease
    Be planning to have any surgical procedure
    Have an implanted mechanical valve prosthesis in any position.
    Have New York Heart Association Class IV Congestive Heart Failure.

Additional Info

The WATCHMAN device will be compared to standard of care. Eligible patients will have 50/50 chance of being randomized, like the flip of a coin, to receive the WATCHMAN device or continued medical management.

Contact Info:

  • Heather Catchpole
  • catchpole.heather@scrippshealth.org
  • 858-824-4248

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

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