Tunisian Registry of Trans Catheter Aortic Valve Implantation (TAVI-TN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tunisian Patients Already Implanted With a TAVI

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Nadhem HAJLAOUI, PI; Phone Number: +21655130873; Email: drnadhemhajlaoui@gmail.com
• Study Contact Backup: Name: Salem ABDESSALEM, MD; Phone Number: +21655333282; Email: salem.abdesselem@gmail.com

Study Locations

• Tunisia
  • Tunis, Tunisia
    • Recruiting
    • Hôpital militaire principal d'instruction de Tunis
    • Contact: Salem ABDESSALEM, MD; Phone Number: +21655333282; Email: salem.abdesselem@gmail.com
    • Contact: Nadhem HAJLAOUI, Pr; Phone Number: +21655130873; Email: drnadhemhajlaoui@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• All Tunisian patients already implanted with a TAVI
• Patients implanted during the period of one year starting from D1 of the registry's launch i.e. 23/09/2023.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint	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	From 30 days post procedure to completion of at least 2 years of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VARC defined 'Device success' composite endpoint	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)	30 days

Collaborators and Investigators

• Sponsor: Les Laboratoires des Médicaments Stériles
• Collaborators: Tunisian Society of Cardiology and Cardiovascular Surgery
• Investigators: Principal Investigator: Nadhem HAJLAOUI, PI, Hôpital militaire principal d'instruction de Tunis

Publications and helpful links

General Publications

• Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2021 Feb;111(2):701-722. doi: 10.1016/j.athoracsur.2020.09.002. Epub 2020 Nov 16.
• Alasnag M, AlMerri K, Almoghairi A, Alenezi A, Bardooli F, Al-Sheikh S, Alanazi N, AlHarbi W, Al Lawati H, Al Faraidy K, AlShehri M, Thabane M, Thabane L, Al-Shaibi K. One-Year Outcomes for Patients Undergoing Transcatheter Aortic Valve Replacement: The Gulf TAVR Registry. Cardiovasc Revasc Med. 2022 Aug;41:19-26. doi: 10.1016/j.carrev.2021.12.024. Epub 2021 Dec 31.
• Didier R, Le Breton H, Eltchaninoff H, Cayla G, Commeau P, Collet JP, Cuisset T, Dumonteil N, Verhoye JP, Beurtheret S, Lefevre T, Iung B, Gilard M; STOP-AS, France-TAVI investigators. Evolution of TAVI patients and techniques over the past decade: The French TAVI registries. Arch Cardiovasc Dis. 2022 Apr;115(4):206-213. doi: 10.1016/j.acvd.2022.04.004. Epub 2022 Apr 27. Erratum In: Arch Cardiovasc Dis. 2022 Jun-Jul;115(6-7):408-409. doi: 10.1016/j.acvd.2022.05.001.
• Tezuka T, Higuchi R, Hagiya K, Saji M, Takamisawa I, Nanasato M, Iguchi N, Shimizu A, Shimizu J, Doi S, Okazaki S, Sato K, Tamura H, Yokoyama H, Onishi T, Tobaru T, Takanashi S, Takayama M. Midterm Outcomes of Underweight Patients Undergoing Transcatheter Aortic Valve Implantation: Insight From the LAPLACE-TAVR Registry. JACC Asia. 2022 Dec 13;3(1):78-89. doi: 10.1016/j.jacasi.2022.08.014. eCollection 2023 Feb.
• Ciardetti N, Ciatti F, Nardi G, Di Muro FM, Demola P, Sottili E, Stolcova M, Ristalli F, Mattesini A, Meucci F, Di Mario C. Advancements in Transcatheter Aortic Valve Implantation: A Focused Update. Medicina (Kaunas). 2021 Jul 14;57(7):711. doi: 10.3390/medicina57070711.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2023
• Primary Completion (Estimated): June 23, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Echocardiography; TAVI; Death; Vascular complications; Pacemaker implantation
• Other Study ID Numbers: TAVI-TN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No