Biventricular Pacing in Children With Congenital Heart Disease

NCT02644824 | Completed

• 1 other identifier: 1000032246
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative morbidity and recovery. Children with CHD undergoing surgery with CPB can experience well-characterized post-operative cardiac dysfunction. When severe, patients can develop clinically important low cardiac output syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which affect the strength of the heart's muscular contractions. These are used to maintain adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to myocardial function and may increase risk for post-operative arrhythmia and impair post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2). In combination with the increased VO2 associated with CPB-induced systemic inflammatory response patients can develop a critical mismatch between oxygen supply and demand, essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic stability without increased VO2 are beneficial. This study will test whether BiVp, a specialized yet simple pacing technique, can improve post-operative CI and recovery in infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 48 hours in infants with EMD following CHD surgery compared to standard care alone.

Conditions

Congenital Heart Disease (CHD)

Keywords

Congenital Heart Disease (CHD); Cardiopulmonary Bypass (CPB); Cardiac Index; Hemodynamics; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Change in Cardiac Index (CI)

  The overall mean change in CI from baseline (average of 1st 2 CI measurements) to study end (average of last 2 measurements) in BiVp vs. controls.

  Pre-operative, baseline, and every 24 hours during care up to 48 hours

Secondary Outcomes (5)

• Duration of Mechanical Ventilation

  From baseline to extubation at 48 hours

• End Organ Perfusion

  Pre-operative, baseline, and every 24 hours during care and up to 48 hours

• QRS Duration

  Pre-operative, baseline, and at study end of 48 hours

• Vasoactive-inotropic Score

  Change from baseline of vasoactive-inotropic score to end of care and up to 48 hours

• Mechanical Dyssynchrony

  Pre-operative, baseline, and at study endat 48 hours

Study Arms (3)

Biventricular Pacing (BiVp)

EXPERIMENTAL

Consented infants with wide QRS randomized to receive standard of care and BiVp.

Device: Biventricular Pacing (BiVp)

Control (wide QRS)

NO INTERVENTION

Consented infants with wide QRS randomized to receive standard of care alone.

Control (narrow QRS)

NO INTERVENTION

This is an observation control group. Consented infants with narrow QRS will enter control group 2 without randomization.

Interventions

Biventricular Pacing (BiVp) DEVICE

BiVp shortens QRS duration and synchronizes ventricular contraction; thereby decreasing wall stress and increasing CI and BP. In contrast to inotropes, BiVp does not increase myocardial VO2. Resynchronizing myocardial contraction normalizes glucose metabolism, myocardial perfusion and distribution of proteins essential to myocardial contraction and relaxation such as calcium-handling phospholamban. Overall, BiVp improves pump function, increases CI, improves myocardial perfusion and reduces VO2, improving hemodynamics.

Biventricular Pacing (BiVp)

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants 0-1 year with Congenital Heart Disease
• Patients with functionally univentricular heart disease
• Informed consent

You may not qualify if:

• Infants \<2.5 kg at time of surgery
• Infants with biventricular heart disease
• Informed consent is not given

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Mark Friedberg, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: January 1, 2016
• Study Start: July 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

CA (1)