Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry
NCT ID: NCT05625607
Last Updated: 2022-11-23
Study Results
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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RECRUITING
100 participants
OBSERVATIONAL
2022-10-17
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Transcatheter mitral valve-in-valve implantation
Transcatheter transfemoral mitral valve-in-valve implantation is an alternative for surgery redo in high-surgical-risk patients with bioprosthetic valve failure. The procedure is performed via femoral vein access. By the transseptal puncture (in the postero-inferior part of the interatrial septum) and balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle. The valve is expanded in the mitral position during rapid ventricle pacing.
Eligibility Criteria
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Inclusion Criteria
* Qualification for TMVR by decision of the local Heart Team
* Patient provided written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute of Cardiology, Warsaw, Poland
OTHER
Medical University of Bialystok
OTHER
University of Opole
OTHER
Medical University of Gdansk
OTHER
Medical University of Silesia
OTHER
Medical University of Lodz
OTHER
Medical University of Warsaw
OTHER
Responsible Party
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Locations
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Medical University of Białystok
Bialystok, , Poland
Medical University of Gdańsk
Gdansk, , Poland
Medical University of Silesia
Katowice, , Poland
Medical University of Łódź
Lodz, , Poland
Medical University of Opole
Opole, , Poland
Medical University of Warsaw
Warsaw, , Poland
Institute of Cardiology
Warsaw, , Poland
Countries
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Facility Contacts
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Marcin Demkow, MD, PhD
Role: backup
References
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Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015 Aug 1;36(29):1878-91. doi: 10.1093/eurheartj/ehv333. Epub 2015 Jul 13.
Other Identifiers
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WUM-MViV
Identifier Type: -
Identifier Source: org_study_id
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