NCT07852390NARecruiting

Postoperative Pacing for Cardiac Efficiency

Robert G. Webster, MD, MPH

Start Date

10/1/2026

Completion Date

12/31/2027

Summary

The goal of this study is to determine whether temporarily increasing a child's heart rate after heart surgery can improve blood flow and oxygen supply to the body's tissues. The study will compare temporary atrial pacing at 10 and 20 beats per minute above the child's natural heart rate with the child's natural heart rate without pacing. Participants will be randomly assigned to one of two schedules for these pacing approaches. Each pacing approach has previously been used as part of routine care after heart surgery. The study will test whether temporarily increasing the heart rate improves blood flow and oxygen supply during the first 10 hours after surgery.

Detailed Description

This study uses a randomized, within-subject design to evaluate three postoperative heart rate conditions: intrinsic sinus rhythm, temporary atrial pacing at 10 beats per minute above the intrinsic sinus rate, and temporary atrial pacing at 20 beats per minute above the intrinsic sinus rate. Participants will be randomized to one of two sequences determining the order in which these conditions are administered. Each pacing condition will be maintained for approximately three hours during the early postoperative period. Participants will be grouped according to single-ventricle or two-ventricle physiology. The study uses a within-subject design so that each participant serves as their own control when comparing physiologic responses to the three heart rate conditions. Continuous physiologic data will be collected during the postoperative study period using the institutional Sickbay physiologic data acquisition platform. Data obtained through routine postoperative monitoring will be used to characterize physiologic responses during and between pacing conditions. No additional physiologic monitoring devices or research-only laboratory testing are required. A secondary component of the study evaluates the electrophysiologic properties of temporary epicardial pacing wires during the postoperative period. We will measure how much electricity is required to pace the heart on the first day after surgery and daily through postoperative day 3. Threshold testing is performed using standard clinical pacing equipment and techniques and only when the treating clinical team determines that testing is clinically appropriate and safe. The study is open-label; neither treating clinicians nor study personnel are blinded to pacing status or pacing rate. Study-specific procedures are limited to the postoperative hospitalization, with data collection continuing through the 3-day postoperative period. After completion or discontinuation of protocol-directed pacing, subsequent pacing and medical management are determined solely by the treating clinical team.

Eligibility Criteria

Age Range: No minimum to 12 years

Inclusion Criteria: * Age less than 12 years (all potential recruitment). Target recruitment will focus on children less than 12 months at enrollment. Children aged 13-36 months will be eligible for recruitment if we do not meet the target recruitment goals for infants according to the study timeline, and then all patients \< 12 years if recruitment is still below targets. * Scheduled for congenital cardiac surgery at Lurie Children's Hospital * Planned postoperative admission to the CICU * Informed consent obtained from parent(s) or legally authorized representative(s) Exclusion Criteria: * Pregnant patient at time of surgery * Category 2 and category 3 patients on the pulmonary artery reconstruction (PAR) program * Junctional or ventricular rhythm at baseline * Uncontrolled tachyarrhythmia (for example, but not limited to, atrial or ventricular tachycardia, atrioventricular re-entrant arrhythmias) * Hemodynamically significant bleeding, defined as active bleeding that, in the judgment of the treating clinical team, requires ongoing blood product transfusion, surgical or catheter-based intervention, or results in hemodynamic instability requiring escalation of clinical support * Postoperative cardiac arrest prior to protocol initiation or during the protocol period * Requirement for mechanical circulatory support * Requirement for ventricular pacing * Arterial pH less than 7.10 * Determination by the treating clinical team that participation is not in the patient's best clinical interest

Interventions

OTHER

Temporary Atrial Pacing

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Conditions

Pacing TherapyPostoperative CarePediatric Congenital Heart SurgeryCardiac PacingPostoperative Cardiac Surgery

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States