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

NCT05625607 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-11-23

No results posted yet for this study

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.

Conditions

  • Mitral Insufficiency
  • Mitral Stenosis
  • Mitral Stenosis With Insufficiency
  • Heart Failure
  • Bioprosthesis Failure

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • National Institute of Cardiology, Warsaw, Poland

    collaborator OTHER

  • Medical University of Bialystok

    collaborator OTHER

  • University of Opole

    collaborator OTHER

  • Medical University of Gdansk

    collaborator OTHER

  • Medical University of Silesia

    collaborator OTHER

  • Medical University of Lodz

    collaborator OTHER

  • Medical University of Warsaw

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2025-12-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05625607 on ClinicalTrials.gov