RecruitingNCT06503965

Tunisian Registry of Trans Catheter Aortic Valve Implantation

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


Sponsor

Les Laboratoires des Médicaments Stériles

Enrollment

300 participants

Start Date

Sep 23, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This Tunisian national registry is collecting comprehensive data on patients who have undergone transcatheter aortic valve implantation (TAVI) — a minimally invasive procedure to replace a narrowed aortic heart valve without open-heart surgery — across multiple Tunisian hospitals between 2013 and 2024. The goal is to document outcomes, procedural details, and patient characteristics to help improve TAVI care in Tunisia and fill a gap in regional data. Any Tunisian patient who has undergone TAVI at a participating center in Tunisia and provides consent is eligible — non-Tunisian patients or those who do not consent are not included. Participation involves sharing existing medical records from the TAVI procedure and follow-up visits, with no additional tests or treatments required. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Hôpital militaire principal d'instruction de Tunis

Tunis, Tunisia

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NCT06503965