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New valve system for severe tricuspid regurgitation

A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV-I Trial

Not applicable Interventional P+F Products + Features USA Inc. · NCT06137807

This study is testing a new valve system for people with severe tricuspid regurgitation who can't have traditional surgery to see if it can safely improve their heart function.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorP+F Products + Features USA Inc. Industry-sponsored
Locations36 sites (Phoenix, Arizona and 35 other locations)
Trial IDNCT06137807 on ClinicalTrials.gov

What this trial studies

The TricValve® Transcatheter Bicaval Valve System is designed for patients with severe tricuspid regurgitation who are at high risk for traditional surgery. This innovative system allows for the replacement of the tricuspid valve using a minimally invasive approach, implanting valves in the superior and inferior vena cava without disturbing the native valve. Patients will be closely monitored for 12 months post-procedure, with long-term safety and efficacy data collected annually for up to five years. The study aims to evaluate the safety and effectiveness of this new valve system in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with severe tricuspid regurgitation and NYHA Class III-IV heart failure symptoms who are not candidates for traditional surgery.

Not a fit: Patients who have had a recent heart attack, stroke, or major cardiovascular surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could significantly improve the quality of life and health outcomes for patients suffering from severe tricuspid regurgitation.

How similar studies have performed: Other studies involving transcatheter valve replacements have shown promising results, suggesting potential success for this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Subject must be 18 years or older, at the time of signing the informed consent.
2. Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
3. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
4. Subject is 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.
5. The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
6. For females of childbearing potential, negative pregnancy test.
7. Capable of giving signed informed consent.

Exclusion Criteria:

1. Subject 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.
2. Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction. Please note that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValve implantation can be performed 30 days after the intervention. Additionally, TricValve implantation can be performed 30 days after any Electrophysiology procedure (pacemaker, ICD, etc.).
3. LVEF ≤ 30% on echocardiography.
4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
5. Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 \[at least 0.75 if BMI \>30 kg/m2\], DVI \<2.2, mean gradient \<5mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild \[1+\]) or acceptable (≤ moderate \[2+\]).
6. Severe right ventricular dysfunction.
7. Cardiac amyloidosis
8. Pulmonary artery systolic pressure (PASP) \>65 mmHg assessed with Echo Doppler and /or right heart catheterization.
9. Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
10. Hemodynamically significant pericardial effusion.
11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure)
12. Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.
13. Unable to tolerate anticoagulation/antiplatelet therapy
14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
15. Any known life-threatening condition with an estimated life span of at least 12 months.
16. Platelet count \< 75,000/mm3
17. Child-Pugh Severity Class C (10-15 points).
18. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.
19. Endocarditis or active/ongoing infection requiring antibiotics.
20. Unable to walk at least 60 meters in a 6minute walk test.
21. Known bleeding or clotting disorders or patient refuses blood transfusion.
22. Active gastrointestinal (GI) bleeding within 3 months of randomization.
23. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
24. Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.
25. Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.
26. Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up
27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.

Where this trial is running

Phoenix, Arizona and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Tricuspid RegurgitationTricuspid Valve DiseaseHeart Failure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.