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

Congenital Heart Disease Clinical Trial

— DAI-T4F  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837574
• Other study ID #: CNIL2029070
• Status: Recruiting
• Start date: December 1, 2010
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2019
• Source: Paris Sudden Death Expertise Center
• Contact: Victor Waldmann, MD
• Phone: +33676098007
• Email: vicrtor.waldmann[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2030
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• tetralogy of Fallot

• implantable cardioverter defibrillator

Exclusion Criteria:

• age < 18 years

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Paris Sudden Death Expertise Center	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Paris Sudden Death Expertise Center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular arrhythmias	Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation	through study completion, an average of 1 year
Primary	Complications of ICD	Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction	through study completion, an average of 1 year