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

Plain Language Summary

Simplified for easier understanding

This study is a Polish national registry tracking the outcomes of patients who receive a catheter-based procedure (done through the leg vein) to replace a failing mitral heart valve without open-heart surgery. Called Mitral Valve-in-Valve implantation, the procedure places a new valve inside the old surgical one. The registry collects real-world data on how safe and effective this approach is. **You may be eligible if...** - You previously had a biological (tissue) mitral valve surgically implanted, and it is now failing (showing moderate or severe narrowing or leaking) - Your heart team has decided you are a candidate for this catheter-based valve replacement - You are willing to provide written consent **You may NOT be eligible if...** - Your heart team has determined you are not suitable for this procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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