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

COVID-19 update:

In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. 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