Status:
COMPLETED
Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
Lead Sponsor:
University of British Columbia
Conditions:
Congenital Heart Defects
Eligibility:
All Genders
1-18 years
Brief Summary
Malformations of the heart (congenital heart disease) are the most common congenital birth defects, occurring in about 1% of children. Each year, between 150-200 children will undergo open heart surge...
Detailed Description
The heart's rhythmic beating or contraction is determined by the flow of an excitatory electrical wave-front along a specialized cardiac conduction system. In the presence of altered conduction, such ...
Eligibility Criteria
Inclusion
- Subjects will be eligible for enrollment in this study if they are undergoing cardiopulmonary bypass surgery for right or left ventricular surgery or biventricular surgery and (1) have intra-cardiac conduction delay or bundle branch block post-surgery; (2) have echocardiographic evidence of ventricular dyssynchrony; (3) have pre-existing conduction disease or bundle branch block; or (4) have pre-existing ventricular dyssynchrony.
Exclusion
- Subjects will be excluded if they: (1) have single ventricle morphology; (2) require post-operative ECMO; (3) have sustained atrial or ventricular arrhythmias that may complicate ventricular pacing; (4) are not able to have functioning epicardial pacemaker leads; (5) are, in the opinion of the intensivist, cardiologist or surgeon, not stable enough medically to participate in the study; or (6) are unwilling to provide informed consent or assent.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00397514
Start Date
October 1 2006
End Date
November 1 2009
Last Update
December 18 2017
Active Locations (1)
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1
Children's Heart Centre, British Columbia's Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4