Actively Recruiting
Led by Paris Sudden Death Expertise Center · Updated on 2019-02-12
150
Participants Needed
1
Research Sites
595 weeks
Total Duration
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
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
Total: 1 location
1
Paris Sudden Death Expertise Center
Paris, France, 75015
Actively Recruiting
V
Victor Waldmann, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Mikael Laredo, Guillaume Duthoit, Frédéric Sacher...
https://pubmed.ncbi.nlm.nih.gov/36309156Victor Waldmann, Abdeslam Bouzeman, Guillaume Duthoit...
https://pubmed.ncbi.nlm.nih.gov/36266008Victor Waldmann, Christelle Marquié, Abdeslam Bouzeman...
https://pubmed.ncbi.nlm.nih.gov/36265962Francis Bessière, Kévin Gardey, Abdeslam Bouzeman...
https://pubmed.ncbi.nlm.nih.gov/33933408Victor Waldmann, Abdeslam Bouzeman, Guillaume Duthoit...
https://pubmed.ncbi.nlm.nih.gov/32998542