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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00397514
First received: November 7, 2006
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Cardiac Index [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Incidence of Low Output Syndrome [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • TDI indices (tissue velocities, tissue tracking, regional strain, and regional strain rates) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Inotropic Support [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Ventilatory Support [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cardiac Resynchronization with Biventricular Pacing
    See Detailed Description.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397514

Locations
Canada, British Columbia
Children's Heart Centre, British Columbia's Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Shubhayan Sanatani, MD Provincial Health Services Authority
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00397514     History of Changes
Other Study ID Numbers: CO3-70642, W05-0117
Study First Received: November 7, 2006
Last Updated: September 28, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Assessing the hemodynamic benefits of cardiac resynchronization therapy in children following open-heart surgery

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013