Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Disqualification from TMVR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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
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