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

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

Recruiting

Interested in participating?

Key information

Conditions

Tetralogy of Fallot Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Defects, Congenital Heart Diseases Implantable Defibrillator User Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Ventricular Arrythmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris Sudden Death Expertise Center

Paris, 75015, France

Location status: Recruiting

Location contact

Victor Waldmann

CONTACT

[email protected]

+33676098007

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

tetralogy of Fallot
implantable cardioverter defibrillator

Exclusion criteria

age < 18 years

Treatment and study plan

Primary outcomes

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
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

Study contacts

Contact information is provided by the study sponsor or research team.

Victor Waldmann, MD

CONTACT

[email protected]

+33676098007

Sponsors and collaborators

Lead sponsor

Paris Sudden Death Expertise Center

Other

Registry information

Acronym: DAI-T4F

Important dates

Study start: 2010
Primary completion: 2019
Study completion: 2030
First posted: Feb 12, 2019
Registry last updated: Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting