Tunisian Patients Already Implanted With a TAVITAVI-TNNCT06503965
Tunisian Registry of Trans Catheter Aortic Valve Implantation
An observational study of Tunisian Patients Already Implanted With a TAVI, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tunisian Patients Already Implanted With a TAVI
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- 23 Sep 2023to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Any Tunisian patient who was treated with TAVI implantation in Tunisia
Who cannot join
- Patients who are not Tunisians
- Patients not agreeing to sign consent, witnesses not agreeing to sign consent (family member)
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Hôpital militaire principal d'instruction de Tunis
Tunis
Nadhem HAJLAOUI, Pr, +21655130873, drnadhemhajlaoui@gmail.com
Salem ABDESSALEM, MD, +21655333282, salem.abdesselem@gmail.com
About this study
Official title: 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.
- Keywords
- TAVI, Death, Vascular complications, Pacemaker implantation, Echocardiography
- Medical subject headings
- Death
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 30 days post procedure to completion of at least 2 years of follow up
Secondary outcomes (1)
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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start23 Sep 2023
- Primary completion23 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tunisian Patients Already Implanted With a TAVIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Responsible party
- Sponsor
- Investigators
- Nadhem HAJLAOUI, PI, Principal investigator, Hôpital militaire principal d'instruction de Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503965
- Sponsor's protocol ID
- TAVI-TN
- Acronym
- TAVI-TN
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33213826Alasnag 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.
PubMed 35033460Didier 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.
PubMed 35527212Tezuka 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.
PubMed 36873767Ciardetti 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.
PubMed 34356992
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Rationale of the National Multicenter Tunisian Registry of Trans Catheter Aortic Valve Implantation Registry
- ClinicalTrials.gov ID
- NCT06503965
- Acronym / sponsor ID
- TAVI-TN / TAVI-TN
- Keywords
- TAVI, Death, Vascular complications, Pacemaker implantation, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Collaborators
- Tunisian Society of Cardiology and Cardiovascular Surgery
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 23 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Any Tunisian patient who was treated with TAVI implantation in Tunisia
Key exclusion criteria (2 listed)
- Patients who are not Tunisians
- Patients not agreeing to sign consent, witnesses not agreeing to sign consent (family member)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
VARC defined 'Device success' composite endpoint
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 33213826Carroll 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.
- Background: PubMed 35033460Alasnag 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.
- Background: PubMed 35527212Didier 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.
- Background: PubMed 36873767Tezuka 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.
- Background: PubMed 34356992Ciardetti 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadhem HAJLAOUI, PI principal investigator
Hôpital militaire principal d'instruction de Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tunisian Patients Already Implanted With a TAVI, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadhem HAJLAOUI, PI (+21655130873, drnadhemhajlaoui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06503965, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.