NCT02534792

Early Revalvulation After Fallot Repair Improves Clinical Outcome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 320 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Aim With this retrospective study, the investigators would like to evaluate and, if possible confirm, whether earlier revalvulation of the right ventricular outflow tract is better than late revalvulation. Up to now, no analysis is done to validate this policy change. Patient selection All patients registered in the database of paediatric and congenital cardiology of the University Hospitals in Leuven, with sufficient follow-up data, and who underwent transannular patching at repair will be included in the study. Methodology and statistical analysis All files will be reviewed for demographic, electrocardiographic, echocardiographic, and outcome data. Besides descriptive statistics, Cox regression will be performed to detect whether the time period between repair and revalvulation influences clinical outcome (defined as death, heart failure hospitalization, redo-revalvulation, implantation of automatic defibrillator, endocarditis).

Conditions

• Tetralogy of Fallot

Interventions

Type	Name	Description
OTHER	Revalvulation

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-08-28
• Last updated: 2016-10-27

Locations

1 site across 1 country: Belgium