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

COVID-19 update:

In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:
IRB-17-6969
Matthew J Price, M.D.
This study will evaluate the safety and effectiveness of the WATCHMAN left atrial appendage closure device in patients that cannot take anti-coagulation medications. Patients will be followed for 5 years and will return for office visits at several intervals and will be contacted by phone about every 6 months.

Inclusion Criteria

  • 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

  • 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