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Tunisian Registry of Trans Catheter Aortic Valve Implantation

NCT ID: NCT06503965

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-23

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tunisian Patients Already Implanted With a TAVI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tunisian Society of Cardiology and Cardiovascular Surgery

OTHER

Sponsor Role collaborator

Les Laboratoires des Médicaments Stériles

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadhem HAJLAOUI, PI

Role: PRINCIPAL_INVESTIGATOR

Hôpital militaire principal d'instruction de Tunis

Locations

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Hôpital militaire principal d'instruction de Tunis

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Nadhem HAJLAOUI, PI

Role: CONTACT

[email protected]
+21655130873

Salem ABDESSALEM, MD

Role: CONTACT

[email protected]
+21655333282

Facility Contacts

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Nadhem HAJLAOUI, Pr

Role: primary

[email protected]
+21655130873

Salem ABDESSALEM, MD

Role: backup

[email protected]
+21655333282

References

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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.

Reference Type BACKGROUND
PMID: 33213826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35033460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35527212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36873767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34356992 (View on PubMed)

Other Identifiers

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TAVI-TN

Identifier Type: -

Identifier Source: org_study_id