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Early Revalvulation After Fallot Repair Improves Clinical Outcome

Completed
Conditions
Tetralogy of Fallot
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
Inclusion Criteria
  • Tetralogy of Fallot patients repaired with transannulaire patch.
Exclusion Criteria
  • None.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
death10 years
Secondary Outcome Measures
NameTimeMethod
re-intervention10 years
endocarditis10 years

Trial Locations

Locations (1)

UZ Leuven

🇧🇪

Leuven, Belgium

UZ Leuven
🇧🇪Leuven, Belgium

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