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Clinical Trials/NCT05625607
NCT05625607
Recruiting
Not Applicable

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

Medical University of Warsaw7 sites in 1 country100 target enrollmentOctober 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Insufficiency
Sponsor
Medical University of Warsaw
Enrollment
100
Locations
7
Primary Endpoint
Rate of myocardial infarction
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 17, 2022
End Date
May 31, 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University of Warsaw
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Rate of myocardial infarction

Time Frame: 1 year

Endpoint described as n=x (y%).

Rate of all-cause mortality

Time Frame: 1 year

Endpoint described as n=x (y%).

Rate of hospitalization

Time Frame: 1 year

Hospitalization for valve-related symptoms or worsening congestive heart failure. Endpoint described as n=x (y%).

Rate of neurological events

Time Frame: 1 year

All stroke, transient ischemic attack (TIA). Endpoint described as n=x (y%).

Rate of valve-related dysfunction

Time Frame: 1 year

Mean transvalvular gradient ≥5mmHg; ≥mitral regurgitation; ≥mild paravalvular leak; left ventricle outflow tract obstruction (LVOTO)- (acute hemodynamic deterioration associated with imaging evidence of LVOTO; mean LVOT pressure gradient increasement ≥10 mmHg compared to the baseline value). Endpoint described as n=x (y%).

Secondary Outcomes

  • Rate of procedural success(30 days)
  • Rate of technical success(at 24 hours)
  • Rate of device success(30 days, 6 month, 1 year)
  • Rate of patient success(1 year)

Study Sites (7)

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