NCT04141137 - TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 9, 2019

Primary Completion Date

May 5, 2021

Study Completion Date

December 2, 2021

Conditions

Severe Tricuspid Regurgitation

Interventions

DEVICE

TricValve® System

The TricValve® Delivery System (catheter) with already pre-mounted biological heart valve is inserted from the femoral vein to access the inferior vena cava (IVC) and superior vena cava (SVC) of the heart under fluoroscopy guidance. The appropriately sized TricValve® is released at the implantation site and positions itself as per the anatomy - self expanding frame.

Trial Locations (10)

1090

Medizinische Universität Wien, Vienna

Unknown

Krankenhaus Nord - Klinik Floridsdorf, Vienna

Hospital Universitari Germans Trias i Pujol, Barcelona

Hospital Universitario Reina Sofia de Córdoba, Córdoba

Hospital Clínico San Carlos, Madrid

Hospital Universitario La Paz, Madrid

Hospital Universitario Ramón y Cajal, Madrid

Hospital Clínico Universitario de Salamanca, Salamanca

Hospital Clínico Universitario de Valladolid, Valladolid

Hospital Universitario Alvaro Cunqueiro, Vigo

All Listed Sponsors

lead

P+F Products + Features GmbH

INDUSTRY