Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.
1 other identifier
observational
450
5 countries
28
Brief Summary
Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2021
CompletedFirst Posted
Study publicly available on registry
November 10, 2021
CompletedStudy Start
First participant enrolled
April 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedApril 3, 2024
April 1, 2024
3.6 years
October 29, 2021
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with readmission for HF
First unplanned readmission for Heart Failure
up to 12 months
Secondary Outcomes (10)
All cause mortality
up to 30 days, up to 6 months, up to 5 years
Percentage of participants with major adverse events
up to 12 months
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
up to 5 years
NYHA functional class
up to 30 days, up to 6 months, up to 5 years
- +5 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, 3100, Austria
Medizinische Universität Wien, Department of Cardiac Surgery
Vienna, 1090, Austria
Medizinische Universität Wien, Universitätsklinik für Innere Medizin II
Vienna, 1090, Austria
Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)
Aalst, 9300, Belgium
RkK gGmbH im Artemed Klinikverbund Freiburg
Freiburg im Breisgau, 79104, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79189, Germany
Klinikum Friedrichshafen
Friedrichshafen, 88048, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
Rems-Murr-Kliniken
Winnenden, 71364, Germany
Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos
Kaunas, Lithuania
Hospital de Galdakao-Usansolo
Galdakao, Bizkaia, 48960, Spain
Hospital Virgen de la Victoria
Málaga, Malaga, 29010, Spain
Parc de Salut Mar
Barcelona, 08003, Spain
Hospital Clinic Barcelona
Barcelona, 08036, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain
Hospital Universitario Reina Sofia de Córdoba
Córdoba, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, 28222, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Central Asturias
Oviedo, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario Alvaro Cunqueiro
Vigo, Spain
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Ignacio J Amat Santos, Dr
Hospital Clínico Universitario de Valladolid
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2021
First Posted
November 10, 2021
Study Start
April 20, 2022
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2028
Last Updated
April 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share