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TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT06137807•P+F Products + Features USA Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe TR deemed by the local Heart Team to be at high risk for tricuspid valve surgery. Patients who meet all of the study inclusion criteria, will be treated with the TricValve System. After the intervention, patients will be followed up closely for 12 months. Long term safety and efficacy data will be collected annually up to 5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+17 more criteria

Locations (36)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Scripps Memorial Hospital La Jolla

San Diego, California, United States

UCSF

San Francisco, California, United States

Delray Medical Center

Delray Beach, Florida, United States

Largo Medical Center

Largo, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Endeavor Health, Glenbrook Hospital

Glenview, Illinois, United States

Chicago Advocate Christ

Palos Park, Illinois, United States

Ascension Medical Group St. Vincent The Heart Center of Indiana

Indianapolis, Indiana, United States

Key Dates

Start Date

July 23, 2024

Primary Completion Date

November 1, 2025

Completion Date

September 1, 2029

Last Updated

June 8, 2025

Enrollment

ESTIMATED participants

Conditions

Tricuspid RegurgitationTricuspid Valve Disease

Interventions

TricValve® Transcatheter Bicaval Valve System

DEVICE

Contacts

Monica Tocchi, MD, PhD

CONTACT

9176841700 m.tocchi@meditrial.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

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