Investigational device for tricuspid valve replacement

Inclusion Criteria

• Be Age 18 years or older.
• Have severe tricuspid regurgitation.
• Be appropriate for transcatheter tricuspid valve replacement.

Exclusion Criteria

• 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.