Tunisian Patients Already Implanted With a TAVI
Conditions
Keywords
TAVI, Death, Vascular complications, Pacemaker implantation, Echocardiography
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.
Interventions
None listed
Sponsors
Tunisian Society of Cardiology and Cardiovascular Surgery
Les Laboratoires des Médicaments Stériles
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Tunisia
Contacts
Primary ContactNadhem HAJLAOUI, PI
Backup ContactSalem ABDESSALEM, MD
Outcome results
None listed