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

Sponsors

Lead Sponsor: Medical University of Warsaw

Collaborator: Institute of Cardiology, Warsaw, Poland
Medical University of Bialystok
University of Opole
Medical University of Gdańsk
Medical University of Silesia
Medical University of Lodz

Source Medical University of Warsaw
Brief 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.

Overall Status Recruiting
Start Date 2022-10-17
Completion Date 2026-05-31
Primary Completion Date 2025-12-31
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Rate of all-cause mortality 1 year
Rate of hospitalization 1 year
Rate of neurological events 1 year
Rate of myocardial infarction 1 year
Rate of valve-related dysfunction 1 year
Secondary Outcome
Measure Time Frame
Rate of technical success at 24 hours
Rate of device success 30 days, 6 month, 1 year
Rate of procedural success 30 days
Rate of patient success 1 year
Enrollment 100
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Transcatheter mitral valve-in-valve implantation

Description: 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.

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - Disqualification from TMVR

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status: Contact:
Medical University of Białystok | Białystok, 15-089, Poland Recruiting Paweł Kralisz, MD, PhD +48 85 746 84 96 [email protected]
Medical University of Gdańsk | Gdańsk, 80-210, Poland Recruiting Dariusz Jagielak, MD, PhD +48 58 584 42 00 [email protected]
Medical University of Silesia | Katowice, 40-055, Poland Recruiting Wojciech Wojakowski, MD,PhD +48 32 359 86 90 [email protected]
Medical University of Opole | Opole, 45-052, Poland Recruiting Jerzy Sacha, MD, PhD +48 77 45 20 660 [email protected]
Medical University of Warsaw | Warsaw, 02-091, Poland Recruiting Maciej Mazurek, MD +48 510265843 [email protected] Zenon Huczek, MD, PhD Principal Investigator Maciej Mazurek, MD Sub-Investigator Kajetan Grodecki, MD, PhD Sub-Investigator
Institute of Cardiology | Warsaw, 04-628, Poland Recruiting Adam Witkowski, MD, PhD +48 22 343 43 42 [email protected]
Medical University of Łódź | Łódź, 90-419, Poland Recruiting Andrzej Walczak, MD, PhD +48 42 201 44 60 [email protected]
Location Countries

Poland

Verification Date

2022-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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