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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05114850
Study type Observational [Patient Registry]
Source P+F Products + Features GmbH
Contact Sandra Scheidl, MSc
Phone +436601148208
Email [email protected]
Status Not yet recruiting
Phase
Start date December 2021
Completion date December 2028

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