TricValve System for Tricuspid Valve Disease
(TRICAV-II Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: P+F Products + Features USA Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System). The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior vena cava (SVC) and inferior vena cava (IVC). The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system. The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.

Eligibility Criteria

This trial is for individuals with severe tricuspid valve disease, specifically those suffering from tricuspid regurgitation. Participants should be experiencing symptoms that significantly impact their daily life or have a high risk of complications from surgery.

Inclusion Criteria

I am 18 years old or older.

The local Heart Team and IEC determine that the patient is eligible

My heart has a severe valve issue confirmed by an echo test.

+4 more

Exclusion Criteria

My kidney function is very low or I am on dialysis.

LVEF ≤ 30% on echocardiography

Pulmonary artery systolic pressure (PASP) >65 mmHg

+24 more

Participant Groups

The study tests the TricValve Transcatheter Bicaval Valve System against optimal medical therapy. The system includes two bovine pericardium leaflet valves mounted on self-expanding stents, inserted via veins in the leg to reach and support the heart's tricuspid valve without disturbing it.

3Treatment groups

Experimental Treatment

Active Control

Group I: TricValve® Device (Device) + Optimal medical therapy (OMT)Experimental Treatment2 Interventions

TricValve® Device (Device) + OMT

Group II: TricValve Single Arm RegistryExperimental Treatment2 Interventions

Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry.

Group III: Optimal medical therapy (OMT) AloneActive Control1 Intervention

OMT can prevent heart attacks and heart failure with medications like blood thinners, cholesterol drugs, and blood pressure meds.