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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05114850
Other study ID # CTS-TRIC-003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2022
Est. completion date December 2028

Study information

Verified date January 2023
Source P+F Products + Features GmbH
Contact Sandra Scheidl, MSc
Phone +436601148208
Email sscheidl@pfcardiovascular.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date December 2028
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Austria Universitätsklinikum St. Pölten St. Poelten Niederoesterreich
Austria Medizinische Universität Wien, Department of Cardiac Surgery Vienna
Austria Medizinische Universität Wien, Universitätsklinik für Innere Medizin II Vienna
Belgium Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ) Aalst
Germany RkK gGmbH im Artemed Klinikverbund Freiburg Freiburg
Germany Universitätsklinikum Freiburg Freiburg
Germany Klinikum Friedrichshafen Friedrichshafen
Germany SLK-Kliniken Heilbronn GmbH Heilbronn
Germany Universitätsklinikum Regensburg Regensburg
Germany Robert-Bosch-Krankenhaus Stuttgart
Germany Rems-Murr-Kliniken Winnenden
Lithuania Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos Kaunas
Spain Hospital Clinic Barcelona Barcelona
Spain Hospital Universitari de Bellvitge Barcelona
Spain Hospital Universitari Germans Trias i Pujol Barcelona
Spain Parc de Salut Mar Barcelona
Spain Hospital Universitario Reina Sofia de Córdoba Córdoba
Spain Hospital de Galdakao-Usansolo Galdakao Bizkaia
Spain Hospital Universitario Lucus Augusti Lugo
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta de Hierro de Majadahonda Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital Virgen de la Victoria Málaga Malaga
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

Sponsors (1)

Lead Sponsor Collaborator
P+F Products + Features GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Lithuania,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with readmission for HF First unplanned readmission for Heart Failure up to 12 months
Secondary All cause mortality Number of patients in terms of all cause mortality up to 30 days, up to 6 months, up to 5 years
Secondary Percentage of participants with major adverse events Percentage of participants with major adverse events up to 12 months
Secondary 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
Secondary Number of patients with readmission for HF First unplanned readmission for Heart Failure up to 5 years
Secondary 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
Secondary Change in BNP/NTproBNP and diuretic dosage Change in BNP/NTproBNP and diuretic dosage before intervention after intervention up to 12 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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