Registry for patients with repaired Tetralogy of Fallot
Multicenter Italian Registry From the Italian Pediatric Cardiology Society (SICP) Working Group (WG) on CMR/CT for the Repaired Tetralogy of Fallot
This study is collecting information from patients who have had surgery for Tetralogy of Fallot to see how their hearts are doing over time using special imaging tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Ospedali Riuniti Academic / other |
| Locations | 1 site (Ancona, The Marches) |
| Trial ID | NCT05288894 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect data on patients with repaired Tetralogy of Fallot who are undergoing cardiac magnetic resonance imaging. The study will gather comprehensive information including surgical history, clinical data, imaging results, and any adverse cardiac events over a period of six years. The registry will focus on evaluating biventricular and atrial volumes, function, and the anatomy of the pulmonary arteries, as well as monitoring for major cardiac events and interventions during follow-up.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients with a history of repaired Tetralogy of Fallot who are undergoing cardiac magnetic resonance imaging.
Not a fit: Patients under the age of 10 or those with other complex cardiac conditions may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of long-term outcomes in patients with repaired Tetralogy of Fallot, potentially improving patient management and care.
How similar studies have performed: Other observational registries in congenital heart disease have shown success in improving patient outcomes and understanding long-term effects, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Repaired - TOF Exclusion Criteria: * Age \< 10 years * Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein * Incomplete CMR exam
Where this trial is running
Ancona, The Marches
- Ccpc — Ancona, The Marches, Italy (Recruiting)
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.