Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with readmission for HF | First unplanned readmission for Heart Failure | up to 12 months |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Scheidl, MSc | Contact | +436601148208 | sscheidl@pfcardiovascular.com | |
| Benjamin Reutterer, Dr | Contact | +4369917237200 | breutterer@pfcardiovascular.com |
| Name | Affiliation | Role |
|---|---|---|
| Ignacio J Amat Santos, Dr | Hospital Clínico Universitario de Valladolid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum St. Pölten | Not yet recruiting | Sankt Pölten | Lower Austria | 3100 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Medizinische Universität Wien, Department of Cardiac Surgery | Not yet recruiting | Vienna | 1090 | Austria |
|
| Medizinische Universität Wien, Universitätsklinik für Innere Medizin II | Not yet recruiting | Vienna | 1090 | Austria |
|
| Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ) | Not yet recruiting | Aalst | 9300 | Belgium |
|
| RkK gGmbH im Artemed Klinikverbund Freiburg | Not yet recruiting | Freiburg im Breisgau | 79104 | Germany |
|
| Universitätsklinikum Freiburg | Not yet recruiting | Freiburg im Breisgau | 79189 | Germany |
|
| Klinikum Friedrichshafen | Not yet recruiting | Friedrichshafen | 88048 | Germany |
|
| SLK-Kliniken Heilbronn GmbH | Not yet recruiting | Heilbronn | 74078 | Germany |
|
| Universitätsklinikum Regensburg | Not yet recruiting | Regensburg | 93053 | Germany |
|
| Robert-Bosch-Krankenhaus | Not yet recruiting | Stuttgart | 70376 | Germany |
|
| Rems-Murr-Kliniken | Not yet recruiting | Winnenden | 71364 | Germany |
|
| Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos | Not yet recruiting | Kaunas | Lithuania |
|
| Hospital de Galdakao-Usansolo | Not yet recruiting | Galdakao | Bizkaia | 48960 | Spain |
|
| Hospital Virgen de la Victoria | Not yet recruiting | Málaga | Malaga | 29010 | Spain |
|
| Parc de Salut Mar | Recruiting | Barcelona | 08003 | Spain |
|
| Hospital Clinic Barcelona | Recruiting | Barcelona | 08036 | Spain |
|
| Hospital Universitari de Bellvitge | Not yet recruiting | Barcelona | 08907 | Spain |
|
| Hospital Universitari Germans Trias i Pujol | Recruiting | Barcelona | Spain |
|
| Hospital Universitario Reina Sofia de Córdoba | Recruiting | Córdoba | Spain |
|
| Hospital Universitario Lucus Augusti | Recruiting | Lugo | 27003 | Spain |
|
| Hospital Universitario Puerta de Hierro de Majadahonda | Not yet recruiting | Madrid | 28222 | Spain |
|
| Hospital Clínico San Carlos | Recruiting | Madrid | Spain |
|
| Hospital Universitario La Paz | Recruiting | Madrid | Spain |
|
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Spain |
|
| Hospital Universitario Central Asturias | Recruiting | Oviedo | Spain |
|
| Hospital Clínico Universitario de Salamanca | Recruiting | Salamanca | Spain |
|
| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | Spain |
|
| Hospital Universitario Alvaro Cunqueiro | Recruiting | Vigo | Spain |
|
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided