Tunisian Registry of Trans Catheter Aortic Valve Implantation

NCT06503965 | Recruiting

• 1 other identifier: TAVI-TN
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Tunisian Patients Already Implanted With a TAVI

Keywords

TAVI; Death; Vascular complications; Pacemaker implantation; Echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• VARC defined 'Device success' composite endpoint

  30 days

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Any Tunisian patient who was treated with TAVI implantation in Tunisia

You may not qualify if:

• Patients who are not Tunisians
• Patients not agreeing to sign consent, witnesses not agreeing to sign consent (family member)

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead
• Tunisian Society of Cardiology and Cardiovascular Surgery: collaborator

Study Sites (1)

Hôpital militaire principal d'instruction de Tunis

Tunis, Tunisia

RECRUITING

Related Publications (5)

• 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.

  PMID: 33213826 BACKGROUND

• 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.

  PMID: 35033460 BACKGROUND

• 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.

  PMID: 35527212 BACKGROUND

• 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.

  PMID: 36873767 BACKGROUND

• 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.

  PMID: 34356992 BACKGROUND

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadhem HAJLAOUI, PI

  Hôpital militaire principal d'instruction de Tunis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadhem HAJLAOUI, PI

CONTACT

+21655130873; drnadhemhajlaoui@gmail.com

Salem ABDESSALEM, MD

CONTACT

+21655333282; salem.abdesselem@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: September 23, 2023
• Primary Completion: June 23, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-07

Locations

TU (1)