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TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV) — TRICAV  

Tricuspid Regurgitation Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06137807
Study type Interventional
Source P+F Products + Features GmbH
Contact Monica Tocchi, MD, PhD
Phone 9176841700
Email m.tocchi@meditrial.net
Status Not yet recruiting
Phase N/A
Start date May 2024
Completion date November 2029
View Details
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