Recruiting

Atrial Pacing

Sponsor:

Robert G. Webster, MD, MPH

Code:

NCT07852390

Conditions

Pacing Therapy

Postoperative Care

Pediatric Congenital Heart Surgery

Cardiac Pacing

Postoperative Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

Interventions

Temporary Atrial Pacing

Study Details

Brief 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.

Conditions

Pacing Therapy

Postoperative Care

Pediatric Congenital Heart Surgery

Cardiac Pacing

Postoperative Cardiac Surgery

Study ID

NCT07852390

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: No pacing, +20 bpm, +10 bpm

Participants first undergo intrinsic sinus rhythm without protocol-directed atrial pacing, followed by temporary atrial pacing at 20 beats per minute above the intrinsic sinus rate and then 10 beats per minute above the intrinsic sinus rate. Each condition is maintained for approximately three hours.

experimental: Group 2: +20 bpm, +10 bpm, no pacing

Participants first undergo temporary atrial pacing at 20 beats per minute above the intrinsic sinus rate, followed by atrial pacing at 10 beats per minute above the intrinsic sinus rate and then intrinsic sinus rhythm without protocol-directed atrial pacing. Each condition is maintained for approximately three hours.

Interventions

Temporary Atrial Pacing

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.

Primary outcome measure

  • Change in Mean Renal Near-Infrared Spectroscopy (NIRS) Across Three Pacing Conditions [ Time Frame: The time frame for the mean renal NIRS will be during the final 30 minutes of each of the approximately 3-hour pacing conditions. ]

Central Contacts and Locations

Central contacts

Robert G Webster, MD, MPH

312-227-4397RGWebster@luriechildrens.org

Jeff Hong, MD

312-227-2525jehong@luriechildrens.org

Locations

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Robert G Webster, MD, MPH

312-227-4397rgwebster@luriechildrens.org

Halley V. Dillenbeck, BArch

312-227-4109hdillenbeck@luriechildrens.org

Principal Investigator:

Robert G Webster, MD, MPH

More Information

Sponsor

Robert G. Webster, MD, MPH

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Renal NIRS
  • Postoperative cardiac pacing
  • Pediatric cardiac surgery
  • Postoperative care
  • Atrial pacing
  • Pediatric cardiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Robert G. Webster, MD, MPH on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.