Heart Diseases, Heart Failure, Heart Valve Diseases, Tricuspid Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Conditions
Keywords
Cardiovascular disease
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.
Interventions
None listed
Sponsors
P+F Products + Features GmbH
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with readmission for HF | up to 12 months | First unplanned readmission for Heart Failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with major adverse events | up to 12 months | Percentage of participants with major adverse events |
| Number of participants with severe adverse events | up to 30 days, up to 6 months, up to 5 years | Number of participants with severe adverse events |
| Number of patients with readmission for HF | up to 5 years | First unplanned readmission for Heart Failure |
| NYHA functional class | up to 30 days, up to 6 months, up to 5 years | Change of New York Heart Association (NYHA) functional class from III or IV to a lower one |
| All cause mortality | up to 30 days, up to 6 months, up to 5 years | Number of patients in terms of all cause mortality |
| Change of the right atrium size | up to 30 days, up to 6 months, up to 5 years | Change of the Right Atrium Size assessed by echocardiography |
| Change of the free valve movement | up to 30 days, up to 6 months, up to 5 years | Change of the free valve movement assessed by echocardiography |
| Valve Device Regurgitation | up to 30 days, up to 6 months, up to 5 years | Number of patients with valve device regurgitation assessed by echocardiography |
| Number of alive patients | up to 30 days, up to 6 months, up to 5 years | Number of alive patients free from reintervention related to TricValve System |
| Change in BNP/NTproBNP and diuretic dosage | up to 12 months | Change in BNP/NTproBNP and diuretic dosage before intervention after intervention |
Countries
Austria, Belgium, Germany, Lithuania, Spain
Contacts
Primary ContactSandra Scheidl, MSc
Backup ContactBenjamin Reutterer, Dr
Outcome results
None listed