Status:
UNKNOWN
Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry
Lead Sponsor:
Medical University of Warsaw
Conditions:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Eligibility:
All Genders
18+ years
Brief 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 popu...
Detailed 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...
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
Exclusion
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03361046
Start Date
January 1 2018
End Date
May 30 2024
Last Update
October 22 2020
Active Locations (12)
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1
Medical University of Bialystok
Bialystok, Poland
2
Polish-American Heart Clinic
Bielsko-Biala, Poland
3
Medical University of Gdansk
Gdansk, Poland
4
Medical University of Silesia
Katowice, Poland