French National Registry Tracking Adults With Tetralogy of Fallot and Implantable Cardioverter Defibrillators
Led by Paris Sudden Death Expertise Center · Updated on 2019-02-12
150
Participants Needed
1
Research Sites
595 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to collect and analyze data from patients with tetralogy of Fallot who have an implantable cardioverter defibrillator ICD for either primary or secondary prevention. The study is a national French registry that includes both retrospective cases before 2010 and prospective cases after 2010 with ongoing follow-up. The goal is to better understand ventricular arrhythmias and complications related to ICDs in this specific population.
Patients included in this registry are those with tetralogy of Fallot who have an ICD implanted. French centers that perform ICD implantations are contacted yearly to include all eligible patients. The study collects all baseline electrocardiograms ECG and reviews endocavitary electrograms EGM. Events are centrally reviewed and adjudicated to ensure consistent data collection.
Participants are followed prospectively with annual updates to monitor the occurrence of ventricular arrhythmias and ICD-related complications. The registry tracks these outcomes for an average of one year after enrollment. This observational study involves no intervention beyond routine clinical care and aims to gather comprehensive data on this patient group over time.
CONDITIONS
Brief Title
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
Research Team
V
Victor Waldmann, MD
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Have an implantable cardioverter defibrillator (ICD) implanted
Be 18 years of age or older
You will not qualify if you...
Are younger than 18 years old
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Long-term Monitoring
Duration - Up to 20 years
Participants with tetralogy of Fallot and an implantable cardioverter defibrillator are observed with annual updates and follow-up to track ventricular arrhythmias and device complications.
Annual visits
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Rapid ventricular tachycardia in patients with tetralogy of Fallot and implantable cardioverter-defibrillator: Insights from the DAI-T4F nationwide registry.
Mikael Laredo, Guillaume Duthoit, Frédéric Sacher...