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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
Medical University of Białystok
RECRUITING
Bialystok
Medical University of Gdańsk
RECRUITING
Gdansk
Medical University of Silesia
RECRUITING
Katowice
Medical University of Łódź
RECRUITING
Lodz
Medical University of Opole
RECRUITING
Opole
Institute of Cardiology
RECRUITING
Warsaw
Medical University of Warsaw
RECRUITING
Warsaw
Time Frame
Start Date: 2022-10-17
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 100
Sponsors
Collaborators: Medical University of Lodz, Medical University of Bialystok, Medical University of Gdansk, Medical University of Silesia, University of Opole, National Institute of Cardiology, Warsaw, Poland
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov