Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Insufficiency, Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, Germany, Lithuania, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.
Overview
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.
Primary outcome measures
- Number of patients with readmission for HF [Time frame: up to 12 months]
Secondary outcome measures (10)
- All cause mortality [Time frame: up to 30 days, up to 6 months, up to 5 years]
- Percentage of participants with major adverse events [Time frame: up to 12 months]
- 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 [Time frame: up to 5 years]
- NYHA functional class [Time frame: up to 30 days, up to 6 months, up to 5 years]
- Change in BNP/NTproBNP and diuretic dosage [Time frame: up to 12 months]
- Change of the right atrium size [Time frame: up to 30 days, up to 6 months, up to 5 years]
- Change of the free valve movement [Time frame: up to 30 days, up to 6 months, up to 5 years]
- Valve Device Regurgitation [Time frame: up to 30 days, up to 6 months, up to 5 years]
- Number of alive patients [Time frame: up to 30 days, up to 6 months, up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 16 centers
- Hospital de Galdakao-Usansolo — Galdakao
- Hospital Virgen de la Victoria — Málaga
- Parc de Salut Mar — Barcelona
- Hospital Clinic Barcelona — Barcelona
- Hospital Universitari de Bellvitge — Barcelona
- Hospital Universitari Germans Trias i Pujol — Barcelona
- Hospital Universitario Reina Sofia de Córdoba — Córdoba
- Hospital Universitario Lucus Augusti — Lugo
- … and 8 more centers
Germany · 7 centers
- RkK gGmbH im Artemed Klinikverbund Freiburg — Freiburg im Breisgau
- Universitätsklinikum Freiburg — Freiburg im Breisgau
- Klinikum Friedrichshafen — Friedrichshafen
- SLK-Kliniken Heilbronn GmbH — Heilbronn
- Universitätsklinikum Regensburg — Regensburg
- Robert-Bosch-Krankenhaus — Stuttgart
- Rems-Murr-Kliniken — Winnenden
Austria · 3 centers
- Universitätsklinikum St. Pölten — Sankt Pölten
- Medizinische Universität Wien, Department of Cardiac Surgery — Vienna
- Medizinische Universität Wien, Universitätsklinik für Innere Medizin II — Vienna
Belgium · 1 center
- Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ) — Aalst
Lithuania · 1 center
- Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos — Kaunas
Identifiers
NCT: NCT05114850 · CTS-TRIC-003