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Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®

Sponsor
P+F Products + Features GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05114850
Collaborator
(none)
450
Enrollment
21
Locations
79.4
Anticipated Duration (Months)
21.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    450 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    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.
    Actual Study Start Date :
    Apr 20, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with readmission for HF [up to 12 months]

      First unplanned readmission for Heart Failure

    Secondary Outcome Measures

    1. All cause mortality [up to 30 days, up to 6 months, up to 5 years]

      Number of patients in terms of all cause mortality

    2. Percentage of participants with major adverse events [up to 12 months]

      Percentage of participants with major adverse events

    3. Number of participants with severe adverse events [up to 30 days, up to 6 months, up to 5 years]

      Number of participants with severe adverse events

    4. Number of patients with readmission for HF [up to 5 years]

      First unplanned readmission for Heart Failure

    5. NYHA functional class [up to 30 days, up to 6 months, up to 5 years]

      Change of New York Heart Association (NYHA) functional class from III or IV to a lower one

    6. Change in BNP/NTproBNP and diuretic dosage [up to 12 months]

      Change in BNP/NTproBNP and diuretic dosage before intervention after intervention

    7. Change of the right atrium size [up to 30 days, up to 6 months, up to 5 years]

      Change of the Right Atrium Size assessed by echocardiography

    8. Change of the free valve movement [up to 30 days, up to 6 months, up to 5 years]

      Change of the free valve movement assessed by echocardiography

    9. Valve Device Regurgitation [up to 30 days, up to 6 months, up to 5 years]

      Number of patients with valve device regurgitation assessed by echocardiography

    10. Number of alive patients [up to 30 days, up to 6 months, up to 5 years]

      Number of alive patients free from reintervention related to TricValve System

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum St. Pölten St. Poelten Niederoesterreich Austria 3100
    2 Medizinische Universität Wien, Department of Cardiac Surgery Vienna Austria 1090
    3 Medizinische Universität Wien, Universitätsklinik für Innere Medizin II Vienna Austria 1090
    4 Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ) Aalst Belgium 9300
    5 Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos Kaunas Lithuania
    6 Hospital de Galdakao-Usansolo Galdakao Bizkaia Spain 48960
    7 Hospital Virgen de la Victoria Málaga Malaga Spain 29010
    8 Parc de Salut Mar Barcelona Spain 08003
    9 Hospital Clinic Barcelona Barcelona Spain 08036
    10 Hospital Universitari de Bellvitge Barcelona Spain 08907
    11 Hospital Universitari Germans Trias i Pujol Barcelona Spain
    12 Hospital Universitario Reina Sofia de Córdoba Córdoba Spain
    13 Hospital Universitario Lucus Augusti Lugo Spain 27003
    14 Hospital Universitario 12 de Octubre Madrid Spain 28041
    15 Hospital Universitario Puerta de Hierro de Majadahonda Madrid Spain 28222
    16 Hospital Clínico San Carlos Madrid Spain
    17 Hospital Universitario La Paz Madrid Spain
    18 Hospital Universitario Ramón y Cajal Madrid Spain
    19 Hospital Clínico Universitario de Salamanca Salamanca Spain
    20 Hospital Clínico Universitario de Valladolid Valladolid Spain
    21 Hospital Universitario Alvaro Cunqueiro Vigo Spain

    Sponsors and Collaborators

    • P+F Products + Features GmbH

    Investigators

    • Principal Investigator: Ignacio J Amat Santos, Dr, Hospital Clínico Universitario de Valladolid

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    P+F Products + Features GmbH
    ClinicalTrials.gov Identifier:
    NCT05114850
    Other Study ID Numbers:
    • CTS-TRIC-003
    First Posted:
    Nov 10, 2021
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by P+F Products + Features GmbH
    Cardiovascular disease
    Additional relevant MeSH terms:
    Heart Diseases
    Heart Valve Diseases
    Tricuspid Valve Insufficiency

    Study Results

    No Results Posted as of May 10, 2022