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

Study Timeline

• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-28
• Study Start: 2015-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

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

Name	Time	Method
death	10 years

Secondary Outcome Measures

Name	Time	Method
re-intervention	10 years
endocarditis	10 years

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium