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

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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

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.


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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





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



Information from the National Library of Medicine

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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

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

Additional Information:

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Responsible Party: Marijon, Principal Investigator Dr Victor WALDMANN, Paris Sudden Death Expertise Center
ClinicalTrials.gov Identifier: NCT03837574     History of Changes
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
Death, Sudden, Cardiac
Tetralogy of Fallot
Death
Cardiovascular Diseases
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Heart Arrest
Death, Sudden