Design and Rationale of the National Multicenter Tunisian Registry of Trans Catheter Aortic Valve Implantation Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tunisian Patients Already Implanted With a TAVI
- Sponsor
- Les Laboratoires des Médicaments Stériles
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement. Despite its increasing adoption worldwide, there re-mains a paucity of data regarding TAVI outcomes in Tunisian patients. In response to this gap in knowledge, the investigators propose the establishment of the Tunisian TAVI Registry, a multicenter initiative aimed at comprehensively documenting the clinical characteristics, procedural de-tails, and short- and long-term outcomes of TAVI procedures across Tunisia. The TAVI.TN registry will enroll consecutive patients undergoing TAVI procedures at participating centers across Tunisia, between 2013 and 2024 with a retrospective arm and a prospective arm. The TAVI-TN Registry represents a significant step towards enhancing our understanding of TAVI outcomes in the Tunisian population. By systematically capturing real-world data, this initiative aims to inform clinical decision-making, improve patient care, and contribute to the advancement of TAVI practices in Tunisia and beyond.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any Tunisian patient who was treated with TAVI implantation in Tunisia
Exclusion Criteria
- •Patients who are not Tunisians
- •Patients not agreeing to sign consent, witnesses not agreeing to sign consent (family member)
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)