N/A N=34

Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery

Congenital Heart Defects

Bottom Line

View on ClinicalTrials.gov: NCT00397514 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcome: Primary: Cardiac Index — 3.39; 3.42; 3.23 L/min/m2

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Congenital Heart Surgery Patients (Procedure)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: University of British Columbia
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Cardiac Index	3.39; 3.42; 3.23	—
SECONDARY Systolic Blood Pressure	—	—
SECONDARY Incidence of Low Output Syndrome	—	—
SECONDARY TDI Indices (Tissue Velocities, Tissue Tracking, Regional Strain, and Regional Strain Rates)	—	—
SECONDARY Inotropic Support	—	—
SECONDARY Ventilatory Support	—	—
SECONDARY QRS Duration	80; 100; 100	—
SECONDARY Cardio-pulmonary Bypass Time	96	—

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 surgery at British Columbia Children's Hospital (BCCH) to repair the defect(s) in their heart. The abnormal structure of the heart or the open heart surgery may cause damage to the electrical system of the heart which can disturb the rhythm of the heart (arrhythmias), prolong recovery or be life-threatening. For this reason, temporary pacing wires are placed in the heart following surgery to ensure the heart rhythm is as normal as possible during the post-operative period (pacing). In recent years, scientists have recognized that pacing the heart from one area is not necessarily the same as pacing it from a different area. In fact, in some individuals with arrhythmias and poor heart function, pacing the heart from different areas can improve the pumping of the heart, resulting in better heart function. This form of treatment is called Cardiac Resynchronization Therapy (CRT) because it endeavours to optimize the pumping of the heart by changing the electrical activation of the heart. CRT has been used to a very limited extent in children. A few pediatric cardiologists have used CRT to help children who are in heart failure. We would like to determine whether pacing the heart from different areas after open heart surgery improves the child's heart function and aids his or her recovery.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00397514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.