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

  • STATUS
    Recruiting
  • End date
    May 30, 2024
  • participants needed
    150
  • sponsor
    Medical University of Warsaw
Updated on 1 March 2022
stenosis
tavi

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.

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.

Details
Condition Aortic Valve Stenosis, Aortic Valve Insufficiency, Ventricular Outflow Obstruction, Left
Treatment Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)
Clinical Study IdentifierNCT03361046
SponsorMedical University of Warsaw
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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