French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator (DAI-T4F)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03837574|
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
|Condition or disease|
|Tetralogy of Fallot Implantable Defibrillator User Congenital Heart Disease Sudden Cardiac Death Ventricular Arrythmia|
- 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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||20 Years|
|Official Title:||French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator|
|Actual Study Start Date :||December 1, 2010|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||December 31, 2030|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837574
|Contact: Victor Waldmann, MDemail@example.com|
|Paris Sudden Death Expertise Center||Recruiting|
|Paris, France, 75015|
|Contact: Victor Waldmann +33676098007 firstname.lastname@example.org|
|Principal Investigator:||Victor Waldmann, MD||Paris Sudden Death Expertise Center|