Tunisian Registry of Trans Catheter Aortic Valve Implantation

Recruiting

• Conditions: Tunisian Patients Already Implanted With a TAVI

• Registration Number: NCT06503965
• Lead Sponsor: Les Laboratoires des Médicaments Stériles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-23
• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-16
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-06-23
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint	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 Outcome Measures

Name	Time	Method
VARC defined 'Device success' composite endpoint	30 days	* Absence of procedural mortality; * Correct positioning of a single prosthetic heart valve into the proper anatomical location; * Intended performance of the prosthetic heart valve (no prosthesis - patient mismatch and mean aortic valve gradient ,20 mmHg or peak velocity ,3 m/s, no moderate or severe prosthetic valve regurgitation)

Trial Locations

Locations (1)

Hôpital militaire principal d'instruction de Tunis; 🇹🇳 Tunis, Tunisia