Early Revalvulation After Fallot Repair Improves Clinical Outcome
- Conditions
- Tetralogy of Fallot
- Interventions
- Other: Revalvulation
- Registration Number
- NCT02534792
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- Tetralogy of Fallot patients repaired with transannulaire patch.
- None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Revalvulation time late Revalvulation Late revalvulation by homograft or percutaneous valve Revalvulation time early Revalvulation Early revalvulation by homograft or percutaneous valve
- Primary Outcome Measures
Name Time Method death 10 years
- Secondary Outcome Measures
Name Time Method endocarditis 10 years re-intervention 10 years
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium