Early Revalvulation After Fallot Repair Improves Clinical Outcome

Tetralogy of Fallot Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534792
• Other study ID #: S58389
• Status: Completed
• Phase: N/A
• First received: August 25, 2015
• Last updated: October 26, 2016
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Tetralogy of Fallot patients repaired with transannulaire patch.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Tetralogy of Fallot

Intervention

Other:
• Revalvulation

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death		10 years	No
Secondary	endocarditis		10 years	No
Secondary	re-intervention		10 years	No