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