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

NCT00397514 | Completed Results

• 1 other identifier: H03-70642
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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 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

Keywords

Biventricular pacing; Congenital heart disease; Tissue Doppler echocardiography

Outcome Measures

Primary Outcomes (1)

• Cardiac Index

  Baseline and after 20 minutes of pacing

Secondary Outcomes (7)

• Systolic Blood Pressure

• Incidence of Low Output Syndrome

• TDI Indices (Tissue Velocities, Tissue Tracking, Regional Strain, and Regional Strain Rates)

• Inotropic Support

• Ventilatory Support

Study Arms (1)

Congenital Heart Surgery Patients

Pacing protocol prior to patient's extubation with 20 min. of either conventional right ventricular (RV) or biventricular (BiV) pacing, preceded and followed by 10 min. of recovery time.

Procedure: Congenital Heart Surgery Patients

Interventions

Congenital Heart Surgery Patients PROCEDURE

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

Congenital Heart Surgery Patients

Eligibility Criteria

• Age: 1 Week - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Children's Heart Centre, British Columbia's Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

The study was limited by a small sample.Our study patients underwent BiV pacing just prior to extubation, by which time myocardial dysfunction may have recovered, so they represented a potentially healthier subset in comparison to adults.

Results Point of Contact

• Title: Dr. Shubhayan Sanatani
• Organization: University of British Columbia

ssanatani@cw.bc.ca

6048752345

Study Officials

• Shubhayan Sanatani, MD

  Provincial Health Services Authority British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 9, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 18, 2017
• Results First Posted: August 30, 2013

Record last verified: 2017-11

Locations

CA (1)