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

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

Detailed Description
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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.

Official Title
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TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.

Conditions
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Heart Failure, Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Insufficiency, Heart Diseases, Heart Valve Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with readmission for HF | First unplanned readmission for Heart Failure | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Number of patients in terms of all cause mortality | up to 30 days, up to 6 months, up to 5 years | 
| Percentage of participants with major adverse events | Percentage of participants with major adverse events | up to 12 months | 
| Number of participants with severe adverse events | Number of participants with severe adverse events | up to 30 days, up to 6 months, up to 5 years | 
| Number of patients with readmission for HF | First unplanned readmission for Heart Failure | up to 5 years | 
| NYHA functional class | Change of New York Heart Association (NYHA) functional class from III or IV to a lower one | up to 30 days, up to 6 months, up to 5 years | 
| Change in BNP/NTproBNP and diuretic dosage | Change in BNP/NTproBNP and diuretic dosage before intervention after intervention | up to 12 months | 
| Change of the right atrium size | Change of the Right Atrium Size assessed by echocardiography | up to 30 days, up to 6 months, up to 5 years | 
| Change of the free valve movement | Change of the free valve movement assessed by echocardiography | up to 30 days, up to 6 months, up to 5 years | 
| Valve Device Regurgitation | Number of patients with valve device regurgitation assessed by echocardiography | up to 30 days, up to 6 months, up to 5 years | 
| Number of alive patients | Number of alive patients free from reintervention related to TricValve System | up to 30 days, up to 6 months, up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular disease