Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®

P+F Products + Features

Status: Enrolling

Conditions: Heart Valve Diseases; Tricuspid Insufficiency; Tricuspid Valve Insufficiency; Heart Failure; Heart Diseases; Tricuspid Regurgitation

Study type: Observational

Funder types: Industry

Identifiers

NCT05114850

CTS-TRIC-003

Details and patient eligibility

About

Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.

Full description

The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.

The study duration for the individual subject will be up to 5 year follow up. The follow-up should be made through pre-established periodic clinical consultations at discharge, 1 month, 6 months, 1 year follow up to 5 years after the procedure. In the consultations, routine exams such as hemogram, renal function, electrocardiogram and echocardiography in order to ascertain the bioprosthesis functioning and its hemodynamic profile are documented as per clinical routine practise.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful treatment with TricValve Transcatheter Bicaval Valves System
• Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent

Exclusion criteria

• no exclusion criterion