Multicenter Italian Registry From the Italian Pediatric Cardiology Society (SICP) Working Group (WG) on CMR/CT for the Repaired Tetralogy of Fallot

Azienda Ospedaliero, Universitaria Ospedali Riuniti1 site in 1 country150 target enrollmentMarch 1, 2021

ConditionsTetralogy of Fallot Cardiac Death, Sudden Cardiac Arrhythmia Cardiac Event

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tetralogy of Fallot
Sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti
Enrollment: 150
Locations: 1
Primary Endpoint: Cardiac death
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The CMR/CT WG of the Italian pediatric cardiology society set up a multi-center observational clinical database of repaired-TOF evaluated. This registry will enroll prospectively patients evaluated by CMR for clinical indication in most of the CHD Italian centers. Data collection will include surgical history, clinical data, imaging data, and also adverse cardiac events for a period of 6 years.

Detailed Description

This is an observational prospective registry that will enroll patients presenting with repaired Tetralogy of Fallot (TOF) undergoing a cardiac magnetic resonance (CMR) imaging study in our recruiting CMR-Laboratories. CMR imaging studies will include the evaluation of biventricular volumes and function, atrial volumes and function, and the Late Gadolinium Enhancement (LGE), along with the evaluation of the anatomy and flow of the main pulmonary arteries and branches. We will also assess the aortic valve for regurgitation and measurement of the aortic size. At follow-up, any interventional or surgical procedures performed and symptoms or any major (Death) and cardiac (cardiac-related hospitalization) events will be collected.

Registry

clinicaltrials.gov

Start Date

March 1, 2021

End Date

March 2027

Last Updated

2 years ago

Study Type

Observational

Sex

All