Investigational device for tricuspid valve replacement
Curtiss Stinis, MD
This study will evaluate the safety and effectiveness of the investigational EVOQUE System combined with optimal medical therapy (OMT) compared to OMT alone for the treatment of patients with severe or greater tricuspid regurgitation.
Be Age 18 years or older.
Have severe tricuspid regurgitation.
Be appropriate for transcatheter tricuspid valve replacement.
Patients must not:
Be unable to walk at least 100 meters in a 6-minute walk test.
Have a prior heart transplant.
Have a prior annuloplasty ring implant.
Be using continuous home oxygen for primary severe COPD.
Have a known bleeding or clotting disorders
The EVOQUE system is a tricuspid valve replacement system that uses a transcatheter procedure with no open-heart surgery.
Eligible patients will be randomized to receive treatment with the EVOQUE System or Optimal Medical Therapy (standard of care), and will have follow-up visits at 30 days, 6 months, 12 months and then annually for up to 5 years.
Search for NCT04482062 at www.clinicaltrials.gov for more information.