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

NCT00397514 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2017-12-18

Study results available
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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.

Conditions

  • Congenital Heart Defects

Interventions

PROCEDURE

Congenital Heart Surgery Patients

undergoing either Biventricular (BiV) pacing or Right Ventricular (RV) Pacing

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Shubhayan Sanatani, MD · Provincial Health Services Authority

Eligibility

Min Age
1 Week
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00397514 on ClinicalTrials.gov