Evaluation of Clinical Outcomes of Transcatheter Aortic Valve-in-Valve Implantation in Polish Population - Observational Multicenter Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Medical University of Warsaw
- Enrollment
- 150
- Locations
- 12
- Primary Endpoint
- VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
- Last Updated
- 5 years ago
Overview
Brief Summary
In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.
Detailed Description
The study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in Polish health centers. Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- •Qualification for TAVI by decision of the local Heart Team
- •Patient provided written informed consent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
Time Frame: From 30 days post procedure to completion of at least 2 years of follow up
* All-cause mortality * All stroke (disabling and non-disabling) * Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure * NYHA (New York Heart Association) class III or IV functional classification of heart failure * Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) \<0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation
Secondary Outcomes
- VARC defined 'Device success' composite endpoint(30 days)
- VARC defined "Early Safety" composite endpoint(30 days)
- VARC defined "Time-related valve safety" composite endpoint(From device implant to completion of at least 2 years of follow up)