Actively Recruiting

Age: 18Years +
All Genders
NCT05625607

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

Led by Medical University of Warsaw · Updated on 2022-11-23

100

Participants Needed

7

Research Sites

188 weeks

Total Duration

On this page

Sponsors

M

Medical University of Warsaw

Lead Sponsor

N

National Institute of Cardiology, Warsaw, Poland

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Failing surgically implanted mitral bioprosthetic valve demonstrating 6 moderate stenosis and/or �b6 moderate insufficiency
  • Qualification for TMVR by decision of the local Heart Team
  • Patient provided written informed consent
Not Eligible

You will not qualify if you...

  • Disqualification from TMVR

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 7 locations

1

Medical University of Białystok

Bialystok, Poland, 15-089

Actively Recruiting

2

Medical University of Gdańsk

Gdansk, Poland, 80-210

Actively Recruiting

3

Medical University of Silesia

Katowice, Poland, 40-055

Actively Recruiting

4

Medical University of Łódź

Lodz, Poland, 90-419

Actively Recruiting

5

Medical University of Opole

Opole, Poland, 45-052

Actively Recruiting

6

Medical University of Warsaw

Warsaw, Poland, 02-091

Actively Recruiting

7

Institute of Cardiology

Warsaw, Poland, 04-628

Actively Recruiting

Loading map...

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here