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NCT Number: NCT06503965

Tunisian Registry of Trans Catheter Aortic Valve Implantation

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  1. VARC defined 'Device success' composite endpoint

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nadhem HAJLAOUI, PI

CONTACT

[email protected]

+21655130873

Salem ABDESSALEM, MD

CONTACT

[email protected]

+21655333282

Sponsors and collaborators

Lead sponsor

Les Laboratoires des Médicaments Stériles

Industry

Collaborators

  • Tunisian Society of Cardiology and Cardiovascular Surgery

Registry information

Official study title

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

Acronym: TAVI-TN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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