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

Sponsor

Paris Sudden Death Expertise Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03837574

Collaborator

(none)

150

Enrollment

Location

241

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Tetralogy of Fallot Implantable Defibrillator User Congenital Heart Disease Sudden Cardiac Death Ventricular Arrythmia

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 [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Dec 31, 2030

Ventricular arrhythmias [through study completion, an average of 1 year]
Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation
Complications of ICD [through study completion, an average of 1 year]
Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction