RECRUITING Not applicable ClinicalTrials.gov

Postoperative Pacing for Cardiac Efficiency

Sponsor: Robert G. Webster, MD, MPH • ClinicalTrials.gov ID: NCT07852390

Registry updated: 2026-10-01

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Temporary Atrial Pacing (Other)
Temporary atrial pacing is delivered using temporary epicardial atrial pacing wires placed during cardiac surgery. During the protocol-directed pacing period, participants receive atrial pacing at either 10 or 20 beats per minute above their intrinsic sinus heart rate, according to their randomly assigned sequence. Each pacing condition is maintained for approximately three hours. The comparison condition is intrinsic sinus rhythm without protocol-directed atrial pacing. The protocol-directed pacing period occurs during approximately the first 10 postoperative hours. Pacing may be temporarily interrupted, skipped, or discontinued at the discretion of the treating clinical team when clinically indicated.

Eligibility criteria

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

Conditions

Pacing Therapy Postoperative Care Pediatric Congenital Heart Surgery Cardiac Pacing Postoperative Cardiac Surgery

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment