Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry

Last updated: October 20, 2020
Sponsor: Medical University of Warsaw
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03361046
WUM-VIV
  • Ages > 18
  • All Genders

Study Summary

In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency

  • Qualification for TAVI by decision of the local Heart Team

  • Patient provided written informed consent

Study Design

Total Participants: 150
Study Start date:
January 01, 2018
Estimated Completion Date:
May 30, 2024

Study Description

The study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in Polish health centers.

Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

Connect with a study center

  • Medical University of Bialystok

    Białystok,
    Poland

    Active - Recruiting

  • Polish-American Heart Clinic

    Bielsko-Biala,
    Poland

    Active - Recruiting

  • Medical University of Gdansk

    Gdańsk,
    Poland

    Active - Recruiting

  • Medical University of Silesia

    Katowice,
    Poland

    Active - Recruiting

  • Jagiellonian University Medical College

    Kraków,
    Poland

    Active - Recruiting

  • Poznan University of Medical Sciences

    Poznań,
    Poland

    Active - Recruiting

  • District Hospital 2

    Rzeszów,
    Poland

    Active - Recruiting

  • Institute of Cardiology

    Warsaw,
    Poland

    Active - Recruiting

  • Medical University of Warsaw

    Warsaw,
    Poland

    Active - Recruiting

  • Wroclaw Medical University

    Wrocław,
    Poland

    Active - Recruiting

  • Silesian Center for Heart Diseases

    Zabrze,
    Poland

    Active - Recruiting

  • Medical University of Lodz

    Łódź,
    Poland

    Active - Recruiting

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