Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.
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 Type
OBSERVATIONAL
Enrollment
450
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, Austria
NOT_YET_RECRUITINGMedizinische Universität Wien, Department of Cardiac Surgery
Vienna, Austria
NOT_YET_RECRUITINGMedizinische Universität Wien, Universitätsklinik für Innere Medizin II
Vienna, Austria
NOT_YET_RECRUITINGDepartment of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)
Aalst, Belgium
Number of patients with readmission for HF
First unplanned readmission for Heart Failure
Time frame: up to 12 months
All cause mortality
Number of patients in terms of all cause mortality
Time frame: 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
Time frame: up to 12 months
Number of participants with severe adverse events
Number of participants with severe adverse events
Time frame: 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
Time frame: up to 5 years
NYHA functional class
Change of New York Heart Association (NYHA) functional class from III or IV to a lower one
Time frame: 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
Time frame: up to 12 months
Change of the right atrium size
Change of the Right Atrium Size assessed by echocardiography
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 30 days, up to 6 months, up to 5 years
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RkK gGmbH im Artemed Klinikverbund Freiburg
Freiburg im Breisgau, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Freiburg
Freiburg im Breisgau, Germany
NOT_YET_RECRUITINGKlinikum Friedrichshafen
Friedrichshafen, Germany
NOT_YET_RECRUITINGSLK-Kliniken Heilbronn GmbH
Heilbronn, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Regensburg
Regensburg, Germany
NOT_YET_RECRUITINGRobert-Bosch-Krankenhaus
Stuttgart, Germany
NOT_YET_RECRUITING...and 18 more locations