NCT03837574

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
57mo left

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Dec 2010Dec 2030

Study Start

First participant enrolled

December 1, 2010

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
11.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

8.7 years

First QC Date

January 27, 2019

Last Update Submit

February 9, 2019

Conditions

Tetralogy of FallotImplantable Defibrillator UserCongenital Heart DiseaseSudden Cardiac DeathVentricular Arrythmia

Keywords

tretalogy of fallotimplantable cardioverter defibrillatorcongenital heart diseasesudden cardiac deathventricular arrhythmia

Outcome Measures

Primary Outcomes (2)

  • Ventricular arrhythmias

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

    through study completion, an average of 1 year

  • Complications of ICD

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

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • tetralogy of Fallot
  • implantable cardioverter defibrillator

You may not qualify if:

  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paris Sudden Death Expertise Center

Paris, 75015, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 36309156DERIVED

  • 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.

    PMID: 36266008DERIVED

  • 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.

    PMID: 36265962DERIVED

  • 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.

    PMID: 33933408DERIVED

  • 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.

    PMID: 32998542DERIVED

MeSH Terms

Conditions

Tetralogy of FallotHeart Defects, CongenitalDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Victor Waldmann, MD

    Paris Sudden Death Expertise Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Waldmann, MD

CONTACT

+33676098007vicrtor.waldmann@inserm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Dr Victor WALDMANN

Study Record Dates

First Submitted

January 27, 2019

First Posted

February 12, 2019

Study Start

December 1, 2010

Primary Completion

August 1, 2019

Study Completion (Estimated)

December 31, 2030

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)