TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)

Recruiting now · Not applicable

Conditions studied: Tricuspid Regurgitation, Tricuspid Valve Disease

In brief

The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

Key facts

Study ID

NCT06137807

Run by

P+F Products + Features USA Inc.

People needed

50

Starts

2024-07-23

Expected to finish

2029-09-01

Last updated by the study team

2025-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• 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.).
• LVEF ≤ 30% on echocardiography.
• Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
• 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+]).
• 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 TricValve procedure.
• Hemodynamically significant pericardial effusion.
• Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure)
• 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
• Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
• Any known life-threatening condition with an estimated life span of at least 12 months.
• Platelet count < 75,000/mm3
• Child-Pugh Severity Class C (10-15 points).
• 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.
• Endocarditis or active/ongoing infection requiring antibiotics.
• Unable to walk at least 60 meters in a 6minute walk test.
• Known bleeding or clotting disorders or patient refuses blood transfusion.
• Active gastrointestinal (GI) bleeding within 3 months of randomization.
• Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
• 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.
• Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.

Where it is running

• Ascension Medical Group St. Vincent The Heart Center of Indiana — Indianapolis, Indiana, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Cardiovascular Institute of the South — Houma, Louisiana, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Largo Medical Center — Largo, Florida, United States (enrolling)
• UPMC Pinnacle — Harrisburg, Pennsylvania, United States (enrolling)
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States (enrolling)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• Houston Methodist — Houston, Texas, United States (enrolling)
• University of Texas (Memorial Hermann) — Houston, Texas, United States (enrolling)
• Intermountain Heart Institute - Intermountain Medical Center — Murray, Utah, United States (enrolling)
• UVA School of Medicine — Charlottesville, Virginia, United States (enrolling)
• Endeavor Health, Glenbrook Hospital — Glenview, Illinois, United States (enrolling)
• Scripps Memorial Hospital La Jolla — San Diego, California, United States (enrolling)
• MedStar Washington Hospital Center — Multiple Locations, Washington, United States (enrolling)
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (enrolling)
• Swedish Medical Center — Seattle, Washington, United States
• Tucson Medical Center — Tucson, Arizona, United States
• UCSF — San Francisco, California, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Chicago Advocate Christ — Palos Park, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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