TricValveŽ Transcatheter Valve System for severe tricuspid regurgitation.

Trial ID:
IRB-24-8441
Matthew J Price, M.D.

Inclusion Criteria

Patients must:

  • Be 18 years or older, at the time of signing the informed consent.
    Have severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
    Have NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
    Be adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic.

Exclusion Criteria

Patients must not:

  • Have had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.
    Have LVEF = 30% on echocardiography.
    Be unable to walk at least 60 meters in a 6minute walk test.
    Have severe right ventricular dysfunction.
    Have Cardiac amyloidosis

Additional Info

Patients who meet all of the eligibility criteria will be treated with the TricValve System. After the intervention, patients will be followed for 12 months. Long term safety and effectiveness data will be collected annually up to 5 years

Contact Info:

  • Clinical Research Services
  • CRSleadership@Scrippshealth.org