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Sponsored by: |
University of British Columbia |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00397514 |
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.
Condition | Intervention | Phase |
---|---|---|
Congenital Heart Defects |
Procedure: Cardiac Resynchronization with Biventricular Pacing |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery |
Estimated Enrollment: | 60 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The study cohort will consist of infants, children, and adolescents (<18 years) who are scheduled to undergo open-heart surgery for CHD. Each year approximately 150-200 patients undergo surgery to repair their CHD (see Section 6.4 for sample size estimates). 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.
Canada, British Columbia | |
Children's Heart Centre, British Columbia's Children's Hospital | |
Vancouver, British Columbia, Canada, V6H 3V4 |
Principal Investigator: | Shubhayan Sanatani, MD | BC Children's Hospital |
Responsible Party: | University of British Columbia ( Dr. Shubhayan Sanatani ) |
Study ID Numbers: | CO3-70642, W05-0117 |
Study First Received: | November 7, 2006 |
Last Updated: | May 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00397514 History of Changes |
Health Authority: | Canada: Health Canada |
Assessing the hemodynamic benefits of cardiac resynchronization therapy in children following open-heart surgery |
Heart Diseases Cardiovascular Abnormalities Congenital Abnormalities Heart Defects, Congenital |
Heart Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |