French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator (DAI-T4F)

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

Study Overview

• Status: Recruiting
• Conditions: Tetralogy of Fallot; Congenital Heart Disease; Implantable Defibrillator User; Ventricular Arrythmia; Sudden Cardiac Death

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Victor Waldmann, MD; Phone Number: +33676098007; Email: vicrtor.waldmann@inserm.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Paris Sudden Death Expertise Center
    • Contact: Victor Waldmann; Phone Number: +33676098007; Email: victor.waldmann@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• tetralogy of Fallot
• implantable cardioverter defibrillator

Exclusion Criteria:

• age < 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Paris Sudden Death Expertise Center
• Investigators: Principal Investigator: Victor Waldmann, MD, Paris Sudden Death Expertise Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: February 9, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 9, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: ventricular arrhythmia; implantable cardioverter defibrillator; sudden cardiac death; congenital heart disease; tretalogy of fallot
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Congenital Abnormalities; Death, Sudden; Cardiovascular Abnormalities; Heart Arrest; Heart Diseases; Death; Arrhythmias, Cardiac; Tetralogy of Fallot; Heart Defects, Congenital; Death, Sudden, Cardiac
• Other Study ID Numbers: CNIL2029070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No