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

Last updated: April 2, 2024
Sponsor: P+F Products + Features GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT05114850
CTS-TRIC-003
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Successful treatment with TricValve Transcatheter Bicaval Valves System
  • Patient/patient's authorized legal guardian gives his consent to participate in thestudy and signed the corresponding inform consent

Exclusion

Exclusion Criteria:

  • no exclusion criterion

Study Design

Total Participants: 450
Study Start date:
April 20, 2022
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Universitätsklinikum St. Pölten

    St. Poelten, Niederoesterreich 3100
    Austria

    Site Not Available

  • Medizinische Universität Wien, Department of Cardiac Surgery

    Vienna, 1090
    Austria

    Site Not Available

  • Medizinische Universität Wien, Universitätsklinik für Innere Medizin II

    Vienna, 1090
    Austria

    Site Not Available

  • Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)

    Aalst, 9300
    Belgium

    Site Not Available

  • RkK gGmbH im Artemed Klinikverbund Freiburg

    Freiburg, 79104
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79189
    Germany

    Site Not Available

  • Klinikum Friedrichshafen

    Friedrichshafen, 88048
    Germany

    Site Not Available

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078
    Germany

    Site Not Available

  • Universitätsklinikum Regensburg

    Regensburg, 93053
    Germany

    Site Not Available

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376
    Germany

    Site Not Available

  • Rems-Murr-Kliniken

    Winnenden, 71364
    Germany

    Site Not Available

  • Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos

    Kaunas,
    Lithuania

    Site Not Available

  • Hospital de Galdakao-Usansolo

    Galdakao, Bizkaia 48960
    Spain

    Site Not Available

  • Hospital Virgen de la Victoria

    Málaga, Malaga 29010
    Spain

    Site Not Available

  • Hospital Clinic Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias i Pujol

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Parc de Salut Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia de Córdoba

    Córdoba,
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Central Asturias

    Oviedo,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Salamanca

    Salamanca,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Hospital Universitario Alvaro Cunqueiro

    Vigo,
    Spain

    Active - Recruiting

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