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

Recruiting

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

• Registration Number: NCT03837574
• Lead Sponsor: Paris Sudden Death Expertise Center

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.

Study Timeline

• Study Start: 2010-12-01
• Study First Submitted: 2019-01-27
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-09
• Last Update Submitted: 2019-02-09
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-12
• Primary Completion: 2019-08-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• tetralogy of Fallot
• implantable cardioverter defibrillator

Exclusion Criteria

• age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Paris Sudden Death Expertise Center; 🇫🇷 Paris, France