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