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

Starting soon · Not applicable

Conditions studied: Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure, Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency

In brief

Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.

Key facts

Study ID: NCT06458907
Run by: P+F Products + Features USA Inc.
People needed: 780
Starts: 2026-08-01
Expected to finish: 2032-11-01
Last updated by the study team: 2026-08-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age between 18 years and 85 years old, at the time of signing the informed consent.
Severe tricuspid regurgitation (TR) and Caval Reflux (CR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab. TVARC criteria will be used for the definition of TR severity.
NYHA Class II-III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
Adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team at the time of TR assessment for eligibility (TTE). OMT includes stable oral diuretic medications.
High risk for open surgery and is appropriate for transcatheter tricuspid therapies according to the local heart team.
Patient is unsuitable for approved transcatheter therapies and is eligible for the TricValve procedure, based on review of screening/baseline data and imaging core lab measurements by Central Screening Committee.
For females of childbearing potential, negative pregnancy test.
Capable and willing to provide signed informed consent

You may not qualify if…

CONCOMITANT PROCEDURES
Patient 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.
Patient 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.
CARDIOVASCULAR CONDITIONS
LVEF ≤ 30% on echocardiography.
Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
Severe right ventricular dysfunction.
Cardiac amyloidosis.
Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or right heart catheterization.
Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to the TricValve procedure.
Hemodynamically significant pericardial effusion.
Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure).
Presence of significant congenital or acquired heart disease such as RV dysplasia, arrhythmogenic RV or other conditions that could interfere with the TricValve procedure.
ALLERGIES / INTOLERANCE
Any known allergy or hypersensitivity to nitinol, bovine tissue, or contrast media that cannot be adequately treated with pre-medication.
Unable to tolerate anticoagulation/antiplatelet therapy
COMORBIDITIES
Any known life-threatening condition with an estimated life span of less than 12 months.
Platelet count < 75,000/mm3
Child-Pugh Severity Class C (10-15 points).
Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.
Endocarditis or active/ongoing infection requiring antibiotics.
Unable to walk at least 100 meters in a 6-minute walk test.
Known bleeding or clotting disorders or patient refuses blood transfusion.

Where it is running

University of Alabama — Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
UC Davis Health — Sacramento, California, United States
Scripps Memorial Hospital La Jolla — San Diego, California, United States
UCSF — San Francisco, California, United States
Kaiser Permanente — San Jose, California, United States
MedStar Washington Hospital Center (MWHC) — Washington D.C., District of Columbia, United States
Delray Medical Center — Delray Beach, Florida, United States
HCA Florida Largo Hospital — Largo, Florida, United States
Tampa General Hospital — Tampa, Florida, United States
Endeavor Health — Glenview, Illinois, United States
Ascension Medical Group St. Vincent The Heart Center of Indiana — Indianapolis, Indiana, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Cardiovascular Institute of the South — Houma, Louisiana, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States
Washington University of St Louis — St Louis, Missouri, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Northwell Hospital — Manhasset, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
Riverside Methodist Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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