Registry of patients with Tetralogy of Fallot using implantable defibrillators
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
This study is creating a national registry to track adult patients in France with Tetralogy of Fallot who have implantable defibrillators, to better understand their health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Paris Sudden Death Expertise Center Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT03837574 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a national registry of adult patients in France who have Tetralogy of Fallot and are using implantable cardioverter defibrillators (ICDs). It includes both retrospective data collection for cases prior to 2010 and prospective follow-up for cases after 2010, with annual updates. The study involves collaboration with all French centers that perform ICD implantation to ensure comprehensive data collection and central adjudication of events, including baseline ECG and endocavitary electrogram reviews.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with Tetralogy of Fallot who have received an implantable cardioverter defibrillator.
Not a fit: Patients under 18 years of age will not benefit from this study as they do not meet the inclusion criteria.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of outcomes and improve management strategies for patients with Tetralogy of Fallot and ICDs.
How similar studies have performed: While similar registries have been established for other congenital heart diseases, this specific registry for Tetralogy of Fallot and ICDs is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * tetralogy of Fallot * implantable cardioverter defibrillator Exclusion Criteria: * age \< 18 years
Where this trial is running
Paris
- Paris Sudden Death Expertise Center — Paris, France (Recruiting)
Study contacts
- Principal investigator: Victor Waldmann, MD — Paris Sudden Death Expertise Center
- Study coordinator: Victor Waldmann, MD
- Email: vicrtor.waldmann@inserm.fr
- Phone: +33676098007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.