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Recruiting NCT03837574

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

— Observational Tetralogy of Fallot Implantable Defibrillator User Congenital Heart Disease Sudden Cardiac Death

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Tetralogy of Fallot, Implantable Defibrillator User, Congenital Heart Disease, Sudden Cardiac Death. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Primary outcome measures

  • Ventricular arrhythmias [Time frame: through study completion, an average of 1 year]
  • Complications of ICD [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • tetralogy of Fallot
  • implantable cardioverter defibrillator

Exclusion criteria

  • age < 18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Paris Sudden Death Expertise Center — Paris

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, PMID 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 PMID 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. PMID 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, Massoul PMID 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, Mansourat PMID 32998542

Identifiers

NCT: NCT03837574 · CNIL2029070

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗