Trials / Recruiting
RecruitingNCT05114850
Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 450 (estimated)
- Sponsor
- P+F Products + Features GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.
Detailed 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.
Conditions
- Tricuspid Regurgitation
- Tricuspid Valve Insufficiency
- Tricuspid Insufficiency
- Heart Failure
- Heart Diseases
- Heart Valve Diseases
Timeline
- Start date
- 2022-04-20
- Primary completion
- 2025-12-01
- Completion
- 2028-12-01
- First posted
- 2021-11-10
- Last updated
- 2024-04-03
Locations
28 sites across 5 countries: Austria, Belgium, Germany, Lithuania, Spain
Source: ClinicalTrials.gov record NCT05114850. Inclusion in this directory is not an endorsement.