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OpenTrials
Completed

NCT Number: NCT02534792

Early Revalvulation After Fallot Repair Improves Clinical Outcome

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tetralogy of Fallot patients repaired with transannulaire patch.

Exclusion criteria

  • None.

Treatment and study plan

Revalvulation

Other

Primary outcomes

  1. death

    Time frame: 10 years

Secondary outcomes

  1. endocarditis

    Time frame: 10 years

  2. re-intervention

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2015
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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