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Early Revalvulation After Fallot Repair Improves Clinical Outcome

NCT ID: NCT02534792

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Tetralogy of Fallot

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Revalvulation time early

Early revalvulation by homograft or percutaneous valve

Revalvulation

Intervention Type OTHER

Revalvulation time late

Late revalvulation by homograft or percutaneous valve

Revalvulation

Intervention Type OTHER

Interventions

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Revalvulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Tetralogy of Fallot patients repaired with transannulaire patch.

Exclusion Criteria

* None.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S58389

Identifier Type: -

Identifier Source: org_study_id