Investigational device for tricuspid valve replacement
- Trial ID:
- IRB-22-7897
- Curtiss Stinis, MD
Inclusion Criteria
Patients must:- Be Age 18 years or older.
- Have severe tricuspid regurgitation.
- Be appropriate for transcatheter tricuspid valve replacement.
Exclusion Criteria
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
Additional Info
- 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.
Contact Info:
- CRS Leadership
- CRSLeadership@scrippshealth.org