Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Implantation Through Common Carotid Artery Access in Polish Population - Observational Multicenter Registry
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Medical University of Warsaw
- Enrollment
- 200
- Locations
- 6
- Primary Endpoint
- VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
- Last Updated
- 5 years ago
Overview
Brief Summary
Transcatheter aortic valve implantation (TAVI) is valuable treatment option for patients, who are at the high risk of surgical aortic valve replacement (AVR). Majority of procedures are performed through femoral arteries, however in some this access cannot be applied. Common carotid artery is one of the alternative routes of delivering the device in those patients. Established registry aims at collecting the data prospectively to assess outcomes of TAVI through common carotid artery.
Detailed Description
The study is a prospective multicenter evaluation of transcatheter aortic valve implantations through common carotid artery 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
- •Qualification for TAVI through common carotid artery 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 "Time-related valve safety" composite endpoint(From device implant to completion of at least 2 years of follow up)
- VARC defined "Early Safety" composite endpoint(30 days)
- VARC defined 'Device success' composite endpoint(30 days)