- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05114850
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.
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sandra Scheidl, MSc
- Phone Number: +436601148208
- Email: sscheidl@pfcardiovascular.com
Study Contact Backup
- Name: Benjamin Reutterer, Dr
- Phone Number: +4369917237200
- Email: breutterer@pfcardiovascular.com
Study Locations
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Vienna, Austria, 1090
- Not yet recruiting
- Medizinische Universität Wien, Department of Cardiac Surgery
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Contact:
- Martin Andreas, Dr
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Vienna, Austria, 1090
- Not yet recruiting
- Medizinische Universität Wien, Universitätsklinik für Innere Medizin II
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Contact:
- Christian Hengstenberg, UnivProf Dr
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Niederoesterreich
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St. Poelten, Niederoesterreich, Austria, 3100
- Not yet recruiting
- Universitätsklinikum St. Pölten
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Contact:
- Julia Mascherbauer, Dr
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Aalst, Belgium, 9300
- Not yet recruiting
- Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)
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Contact:
- Liesbeth Rosseel, Dr
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Freiburg, Germany, 79104
- Not yet recruiting
- RkK gGmbH im Artemed Klinikverbund Freiburg
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Contact:
- Tilmann Schwab, MD
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Freiburg, Germany, 79189
- Not yet recruiting
- Universitatsklinikum Freiburg
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Contact:
- Martin Czerney, MD
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Friedrichshafen, Germany, 88048
- Not yet recruiting
- Klinikum Friedrichshafen
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Contact:
- Jochen Wöhrle, MD
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Heilbronn, Germany, 74078
- Not yet recruiting
- SLK-Kliniken Heilbronn GmbH
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Contact:
- Marcus Hennersdorf, MD
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Regensburg, Germany, 93053
- Not yet recruiting
- Universitätsklinikum Regensburg
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Contact:
- Bernhard Unsöld, MD
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Stuttgart, Germany, 70376
- Not yet recruiting
- Robert-Bosch-Krankenhaus
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Contact:
- Phillip Nikolai, MD
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Winnenden, Germany, 71364
- Not yet recruiting
- Rems-Murr-Kliniken
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Contact:
- A. Jeron, MD
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Kaunas, Lithuania
- Not yet recruiting
- Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos
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Contact:
- Rimantas Benetis, Dr
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Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic Barcelona
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Contact:
- Xavier Freixa Rofastes, Dr
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Barcelona, Spain
- Recruiting
- Hospital Universitari Germans Trias i Pujol
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Contact:
- Xavier Suarez, Dr
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Barcelona, Spain, 08003
- Recruiting
- Parc de Salut Mar
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Contact:
- Beatriz Vaquerizo Montilla, Dr
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Barcelona, Spain, 08907
- Not yet recruiting
- Hospital Universitari de Bellvitge
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Contact:
- Joan Antoni Gomez, Dr
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Córdoba, Spain
- Recruiting
- Hospital Universitario Reina Sofia de Cordoba
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Contact:
- Manuel Pan Alvarez, Dr
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Lugo, Spain, 27003
- Recruiting
- Hospital Universitario Lucus Augusti
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Contact:
- Raymundo Ocaranza Sánchez, Dr
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Madrid, Spain
- Recruiting
- Hospital Universitario La Paz
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Contact:
- Raul Moreno, Dr
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Madrid, Spain
- Recruiting
- Hospital Universitario Ramon Y Cajal
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Contact:
- Ángel Sánchez Recalde, Dr
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Madrid, Spain
- Recruiting
- Hospital Clinico San Carlos
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Contact:
- Luis Nombela Franco, Dr
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Madrid, Spain, 28222
- Not yet recruiting
- Hospital Universitario Puerta de Hierro de Majadahonda
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Contact:
- Maria del Trigo Espinosa, Dr
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Oviedo, Spain
- Recruiting
- Hospital Universitario Central Asturias
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Contact:
- César Morís, MD
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Salamanca, Spain
- Recruiting
- Hospital Clinico Universitario de Salamanca
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Contact:
- Ignacio Cruz, Dr
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Valladolid, Spain
- Recruiting
- Hospital Clinico Universitario de Valladolid
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Contact:
- Ignacio J Amat Santos, Dr
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Vigo, Spain
- Recruiting
- Hospital Universitario Alvaro Cunqueiro
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Contact:
- Andrés Iniguez Romo, Dr
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Bizkaia
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Galdakao, Bizkaia, Spain, 48960
- Not yet recruiting
- Hospital de Galdakao-Usansolo
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Contact:
- Jose R Rumoroso, Dr
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Malaga
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Málaga, Malaga, Spain, 29010
- Not yet recruiting
- Hospital Virgen de la Victoria
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Contact:
- Jose M Hernandez, Dr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with readmission for HF
Time Frame: up to 12 months
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First unplanned readmission for Heart Failure
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up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cause mortality
Time Frame: up to 30 days, up to 6 months, up to 5 years
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Number of patients in terms of all cause mortality
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up to 30 days, up to 6 months, up to 5 years
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Percentage of participants with major adverse events
Time Frame: up to 12 months
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Percentage of participants with major adverse events
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up to 12 months
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Number of participants with severe adverse events
Time Frame: up to 30 days, up to 6 months, up to 5 years
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Number of participants with severe adverse events
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up to 30 days, up to 6 months, up to 5 years
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Number of patients with readmission for HF
Time Frame: up to 5 years
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First unplanned readmission for Heart Failure
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up to 5 years
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NYHA functional class
Time Frame: up to 30 days, up to 6 months, up to 5 years
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Change of New York Heart Association (NYHA) functional class from III or IV to a lower one
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up to 30 days, up to 6 months, up to 5 years
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Change in BNP/NTproBNP and diuretic dosage
Time Frame: up to 12 months
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Change in BNP/NTproBNP and diuretic dosage before intervention after intervention
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up to 12 months
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Change of the right atrium size
Time Frame: up to 30 days, up to 6 months, up to 5 years
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Change of the Right Atrium Size assessed by echocardiography
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up to 30 days, up to 6 months, up to 5 years
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Change of the free valve movement
Time Frame: up to 30 days, up to 6 months, up to 5 years
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Change of the free valve movement assessed by echocardiography
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up to 30 days, up to 6 months, up to 5 years
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Valve Device Regurgitation
Time Frame: up to 30 days, up to 6 months, up to 5 years
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Number of patients with valve device regurgitation assessed by echocardiography
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up to 30 days, up to 6 months, up to 5 years
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Number of alive patients
Time Frame: up to 30 days, up to 6 months, up to 5 years
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Number of alive patients free from reintervention related to TricValve System
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up to 30 days, up to 6 months, up to 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ignacio J Amat Santos, Dr, Hospital Clinico Universitario de Valladolid
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTS-TRIC-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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