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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03837574
Acronym
DAI-T4F
Enrollment
150
Registered
2019-02-12
Start date
2010-12-01
Completion date
2030-12-31
Last updated
2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Implantable Defibrillator User, Sudden Cardiac Death, Tetralogy of Fallot, Ventricular Arrythmia

Keywords

tretalogy of fallot, implantable cardioverter defibrillator, congenital heart disease, sudden cardiac death, ventricular arrhythmia

Brief summary

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.

Interventions

None listed

Sponsors

Paris Sudden Death Expertise Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* tetralogy of Fallot * implantable cardioverter defibrillator

Exclusion criteria

* age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Ventricular arrhythmiasthrough study completion, an average of 1 yearRate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation
Complications of ICDthrough study completion, an average of 1 yearRate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction

Countries

France

Contacts

Primary ContactVictor Waldmann, MD
vicrtor.waldmann@inserm.fr+33676098007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026