TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- P+F Products + Features GmbH
- Enrollment
- 450
- Locations
- 28
- Primary Endpoint
- Number of patients with readmission for HF
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of patients with readmission for HF
Time Frame: up to 12 months
First unplanned readmission for Heart Failure
Secondary Outcomes
- Change in BNP/NTproBNP and diuretic dosage(up to 12 months)
- All cause mortality(up to 30 days, up to 6 months, up to 5 years)
- NYHA functional class(up to 30 days, up to 6 months, up to 5 years)
- Percentage of participants with major adverse events(up to 12 months)
- Number of patients with readmission for HF(up to 5 years)
- Number of participants with severe adverse events(up to 30 days, up to 6 months, up to 5 years)
- Change of the right atrium size(up to 30 days, up to 6 months, up to 5 years)
- Change of the free valve movement(up to 30 days, up to 6 months, up to 5 years)
- Valve Device Regurgitation(up to 30 days, up to 6 months, up to 5 years)
- Number of alive patients(up to 30 days, up to 6 months, up to 5 years)