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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837574
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Marijon, Paris Sudden Death Expertise Center

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.

Condition or disease
Tetralogy of Fallot Implantable Defibrillator User Congenital Heart Disease Sudden Cardiac Death Ventricular Arrythmia

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
Actual Study Start Date : December 1, 2010
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Ventricular arrhythmias [ Time Frame: through study completion, an average of 1 year ]
    Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation

  2. Complications of ICD [ Time Frame: through study completion, an average of 1 year ]
    Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients with tetralogy of Fallot and implantablle cardioverter defibrillator in France
Criteria

Inclusion Criteria:

  • tetralogy of Fallot
  • implantable cardioverter defibrillator

Exclusion Criteria:

  • age < 18 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837574


Contacts
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Contact: Victor Waldmann, MD +33676098007 vicrtor.waldmann@inserm.fr

Locations
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France
Paris Sudden Death Expertise Center Recruiting
Paris, France, 75015
Contact: Victor Waldmann    +33676098007    victor.waldmann@inserm.fr   
Sponsors and Collaborators
Paris Sudden Death Expertise Center
Investigators
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Principal Investigator: Victor Waldmann, MD Paris Sudden Death Expertise Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Bessière F, Gardey K, Bouzeman A, Duthoit G, Koutbi L, Labombarda F, Marquié 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, Massoulié G, Mathiron A, Maury P, Nguyen C, Ninni S, Perier MC, Pierre B, Sacher F, Walton C, Winum P, Martins R, Pasquié 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, Marquié 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, Massoulié 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, Pasquié 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.

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Responsible Party: Marijon, Principal Investigator Dr Victor WALDMANN, Paris Sudden Death Expertise Center
ClinicalTrials.gov Identifier: NCT03837574    
Other Study ID Numbers: CNIL2029070
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marijon, Paris Sudden Death Expertise Center:
tretalogy of fallot
implantable cardioverter defibrillator
congenital heart disease
sudden cardiac death
ventricular arrhythmia
Additional relevant MeSH terms:
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Heart Diseases
Arrhythmias, Cardiac
Heart Defects, Congenital
Death, Sudden, Cardiac
Tetralogy of Fallot
Death
 Cardiovascular Diseases
Pathologic Processes
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Arrest
Death, Sudden