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Tetralogy of FallotDAI-T4FNCT03837574

French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

An observational study of Tetralogy of Fallot and Implantable Defibrillator User, run by Paris Sudden Death Expertise Center at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator. Read more about this study

Who is it for?
Ages 18 years and older
How many people
150 participants
Where
1 siteFrance
Study dates
1 Dec 2010to 31 Dec 2030
How long will I take part?
20 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patients with tetralogy of Fallot and implantablle cardioverter defibrillator in France

Who may be able to join

  • tetralogy of Fallot
  • implantable cardioverter defibrillator

Who cannot join

  • age < 18 years

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Victor Waldmann, MD contact

+33676098007

vicrtor.waldmann@inserm.fr

France1 site, 1 recruiting

  • Paris Sudden Death Expertise Center

    Paris, 75015

    Victor Waldmann, +33676098007, victor.waldmann@inserm.fr

    Recruiting

Other trials in France

About this study

National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.

Read the detailed description

Inclusion criteria:

  • patient with tetralogy of Fallot > 18 years
  • implantable cardioverter defibrillator (ICD)
  • primary or secondary prevention

All french centers performing ICD implantation are annually contacted to include all patients with tetralogy of Fallot and ICD.

Retrospective inclusion of cases before 2010 and prospective inclusion after 2010 with prospective follow up and annual update.

All events are centrally adjudicated with collection of all baseline ECG and reviewing of endocavitary EGM.

Keywords
tretalogy of fallot, implantable cardioverter defibrillator, congenital heart disease, sudden cardiac death, ventricular arrhythmia
Medical subject headings
Tetralogy of Fallot, Heart Defects, Congenital, Death, Sudden, Cardiac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventricular arrhythmias

    Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation

    Measured: through study completion, an average of 1 year

  2. Complications of ICD

    Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2019
  2. Study start1 Dec 2010
  3. Primary completion1 Aug 2019 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Prospective
Enrolment
150 participants (estimated)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03837574
Sponsor's protocol ID
CNIL2029070
Acronym
DAI-T4F
Status last verified
Feb 2019
First submitted
27 Jan 2019
Last updated
12 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laredo M, Duthoit G, Sacher F, Anselme F, Audinet C, Bessiere F, Bordachar P, Bouzeman A, Boveda S, Bun SS, Chassignolle M, Clerici G, Da Costa A, de Guillebon M, Defaye P, Elbaz N, Eschalier R, Extramiana F, Fauchier L, Hermida A, Gandjbakhch E, Garcia R, Gourraud JB, Guenancia C, Guy-Moyat B, Irles D, Iserin L, Jourda F, Koutbi L, Labombarda F, Ladouceur M, Lagrange P, Lellouche N, Mansourati J, Marquie C, Martins R, Massoulie G, Mathiron A, Maury P, Messali A, Milhem A, Mondoly P, Nguyen C, Ninni S, Pasquie JL, Pierre B, Pujadas P, Sellal JM, Thambo JB, Walton C, Winum P, Zakine C, Zhao A, Jouven X, Combes N, Marijon E, Waldmann V; DAI-T4F Investigators. Rapid ventricular tachycardia in patients with tetralogy of Fallot and implantable cardioverter-defibrillator: Insights from the DAI-T4F nationwide registry. Heart Rhythm. 2023 Feb;20(2):252-260. doi: 10.1016/j.hrthm.2022.10.016. Epub 2022 Oct 26.

    PubMed 36309156

  • Waldmann V, Bouzeman A, Duthoit G, Koutbi L, Bessiere F, Labombarda F, Marquie C, Gourraud JB, Mondoly P, Sellal JM, Bordachar P, Hermida A, Al Arnaout A, Anselme F, Audinet C, Bernard Y, Boveda S, Bun SS, Chassignolle M, Clerici G, Da Costa A, de Guillebon M, Defaye P, Elbaz N, Eschalier R, Garcia R, Guenancia C, Guy-Moyat B, Halimi F, Irles D, Iserin L, Jourda F, Ladouceur M, Lagrange P, Laredo M, Mansourati J, Massoulie G, Mathiron A, Maury P, Messali A, Narayanan K, Nguyen C, Ninni S, Perier MC, Pierre B, Pujadas P, Sacher F, Sagnol P, Sharifzadehgan A, Walton C, Winum P, Zakine C, Fauchier L, Martins R, Pasquie JL, Thambo JB, Jouven X, Combes N, Marijon E. Sex Differences in Outcomes of Tetralogy of Fallot Patients With Implantable Cardioverter-Defibrillators. JACC Clin Electrophysiol. 2022 Oct;8(10):1304-1314. doi: 10.1016/j.jacep.2022.06.024. Epub 2022 Sep 28.

    PubMed 36266008

  • Waldmann V, Marquie C, Bouzeman A, Duthoit G, Thambo JB, Koutbi L, Maltret A, Pasquie JL, Combes N, Marijon E. Subcutaneous vs Transvenous Implantable Cardioverter-Defibrillator Therapy in Patients With Tetralogy of Fallot. J Am Coll Cardiol. 2022 Oct 25;80(17):1701-1703. doi: 10.1016/j.jacc.2022.08.761. No abstract available.

    PubMed 36265962

  • Bessiere F, Gardey K, Bouzeman A, Duthoit G, Koutbi L, Labombarda F, Marquie C, Gourraud JB, Mondoly P, Sellal JM, Bordachar P, Hermida A, Anselme F, Asselin A, Audinet C, Bernard Y, Boveda S, Chevalier P, Clerici G, da Costa A, de Guillebon M, Defaye P, Eschalier R, Garcia R, Guenancia C, Guy-Moyat B, Henaine R, Irles D, Iserin L, Jourda F, Ladouceur M, Lagrange P, Laredo M, Mansourati J, Massoulie G, Mathiron A, Maury P, Nguyen C, Ninni S, Perier MC, Pierre B, Sacher F, Walton C, Winum P, Martins R, Pasquie JL, Thambo JB, Jouven X, Combes N, Di Filippo S, Marijon E, Waldmann V. Impact of Pulmonary Valve Replacement on Ventricular Arrhythmias in Patients With Tetralogy of Fallot and Implantable Cardioverter-Defibrillator. JACC Clin Electrophysiol. 2021 Oct;7(10):1285-1293. doi: 10.1016/j.jacep.2021.02.022. Epub 2021 Apr 28.

    PubMed 33933408

  • Waldmann V, Bouzeman A, Duthoit G, Koutbi L, Bessiere F, Labombarda F, Marquie C, Gourraud JB, Mondoly P, Sellal JM, Bordachar P, Hermida A, Anselme F, Asselin A, Audinet C, Bernard Y, Boveda S, Bru P, Bun SS, Clerici G, Da Costa A, de Guillebon M, Defaye P, Elbaz N, Eschalier R, Garcia R, Guenancia C, Guy-Moyat B, Halimi F, Irles D, Iserin L, Jourda F, Ladouceur M, Lagrange P, Laredo M, Mansourati J, Massoulie G, Mathiron A, Maury P, Messali A, Narayanan K, Nguyen C, Ninni S, Perier MC, Pierre B, Pujadas P, Sacher F, Sagnol P, Sharifzadehgan A, Walton C, Winum P, Zakine C, Fauchier L, Martins R, Pasquie JL, Thambo JB, Jouven X, Combes N, Marijon E; DAI-T4F Investigators*. Long-Term Follow-Up of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator: The DAI-T4F Nationwide Registry. Circulation. 2020 Oct 27;142(17):1612-1622. doi: 10.1161/CIRCULATIONAHA.120.046745. Epub 2020 Oct 1.

    PubMed 32998542

Questions about this trial

What is this clinical trial studying?

An observational study of Tetralogy of Fallot and Implantable Defibrillator User, run by Paris Sudden Death Expertise Center at 1 site in France.

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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Feb 2019. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Victor Waldmann, MD (+33676098007, vicrtor.waldmann@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventricular arrhythmias (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT03837574, 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 12 Feb 2019.

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