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Clinical Trials/NCT06503965
NCT06503965
Recruiting
Not Applicable

Design and Rationale of the National Multicenter Tunisian Registry of Trans Catheter Aortic Valve Implantation Registry

Les Laboratoires des Médicaments Stériles1 site in 1 country300 target enrollmentSeptember 23, 2023

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.

Registry
clinicaltrials.gov
Start Date
September 23, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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