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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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 details

Aortic Valve Stenosis, Aortic Valve Insufficiency, Ventricular Outflow Obstruction, Left

NCT03361046

Medical University of Warsaw

25 January 2024

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