Registry of patients with Tetralogy of Fallot using implantable defibrillators
Official title: French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
Run by Paris Sudden Death Expertise Center · NCT03837574 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Paris Sudden Death Expertise Center Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | December 1, 2010 |
| Main results expected | August 1, 2019 |
| Study ends | December 31, 2030 |
| Registry record updated | February 12, 2019 |
| Trial ID | NCT03837574 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients under 18 years of age will not benefit from this study as they do not meet the inclusion criteria.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar registries have been established for other congenital heart diseases, this specific registry for Tetralogy of Fallot and ICDs is novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * tetralogy of Fallot * implantable cardioverter defibrillator Exclusion Criteria: * age \< 18 years
Where it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.