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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Stenosis Aortic Valve Insufficiency Ventricular Outflow Obstruction, Left

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transcatheter Aortic Valve-in-Valve Implantation Cohort

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

Intervention Type DEVICE

Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses

Interventions

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

Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses

Intervention Type DEVICE

Other Intervention Names

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Transcatheter Aortic Valve-in-Valve Replacement (ViV-TAVR)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No