RecruitingNCT05625607

Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry

Evaluation of Clinical Outcomes of Transcatheter Transfemoral Mitral Valve-in-Valve Implantation in Polish Population- Observational Multicenter Registry


Sponsor

Medical University of Warsaw

Enrollment

100 participants

Start Date

Oct 17, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. Significantly burdened ones are oftentimes disqualified or not referred to surgery redo. An emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. This technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (TAVI). Recent papers prove that transcatheter mitral valve replacement (TMVR) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. However, data regarding the Polish population are limited. Therefore, the aim of the study is to create a nationwide registry, collecting data from all Polish centers performing TMVR in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after TMVR as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
  • Qualification for TMVR by decision of the local Heart Team
  • Patient provided written informed consent

Exclusion Criteria1

  • \- Disqualification from TMVR

Interventions

PROCEDURETranscatheter 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.


Locations(7)

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

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NCT05625607


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