Pacing TherapyPOSTPACENCT07852390
Postoperative Pacing for Cardiac Efficiency
A study testing Temporary Atrial Pacing in people with Pacing Therapy and Postoperative Care, run by Robert G. Webster, MD, MPH at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Pacing Therapy, Postoperative Care, Pediatric Congenital Heart Surgery
- What is being tested?
- Temporary Atrial Pacing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Robert G Webster, MD, MPH, 312-227-4397, rgwebster@luriechildrens.org
Halley V. Dillenbeck, BArch, 312-227-4109, hdillenbeck@luriechildrens.org
About this study
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.
Read the 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.
- Conditions
- Pacing Therapy, Postoperative Care, Pediatric Congenital Heart Surgery, Cardiac Pacing, Postoperative Cardiac Surgery
- Being tested
- Temporary Atrial Pacing
- Keywords
- Renal NIRS, Postoperative cardiac pacing, Pediatric cardiac surgery, Postoperative care, Atrial pacing, Pediatric cardiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Atrial PacingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: No pacing, +20 bpm, +10 bpm | Experimental | 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. Receives: Other: Temporary Atrial Pacing |
| Group 2: +20 bpm, +10 bpm, no pacing | Experimental | 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. Receives: Other: Temporary Atrial Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Renal Near-Infrared Spectroscopy (NIRS) Across Three Pacing Conditions
Renal near-infrared spectroscopy (NIRS) is a noninvasive monitor that estimates the amount of oxygen in blood within the tissues of the kidney. Renal NIRS will be continuously measured during each of the three study conditions: intrinsic sinus rhythm without protocol-directed pacing, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. The mean renal NIRS value during the final 30 minutes of each approximately 3-hour condition will be used for analysis. The primary outcome will assess the change in mean renal NIRS across the three pacing conditions, with each participant serving as their own control. Expected values for renal NIRS in post-operative cardiac surgery patients with congenital heart disease range from 45% to > 95%.
Measured: The time frame for the mean renal NIRS will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Secondary outcomes (10)
Change in Cerebral NIRS Across Three Pacing Conditions
Cerebral near-infrared spectroscopy (NIRS) is a noninvasive monitor that estimates the amount of oxygen in blood within brain tissue. Cerebral NIRS will be measured during the three study conditions: intrinsic sinus rhythm without protocol-directed pacing, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Expected values for cerebral NIRS in post-operative cardiac surgery patients with congenital heart disease range from 45% to > 95%.
Measured: The time frame for the cerebral NIRS will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change Mean Arterial Pressure Across Three Pacing Conditions
Mean arterial pressure is an estimate of the average pressure in the arteries during a heartbeat and is routinely monitored after cardiac surgery. Mean arterial pressure will be recorded during the three study conditions. The mean value during the final 30 minutes of each approximately 3-hour condition will be compared across intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Expected ranges vary by age, sex and height (e.g., PMID: 28827377) and are adjusted for post-surgical status as opposed to ambulatory screening and management.
Measured: The time frame for the mean arterial pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change in Mean Arterial Oxygen Saturation Across Three Pacing Conditions
Arterial oxygen saturation is the percentage of hemoglobin in the blood that is carrying oxygen. It will be monitored during the three study conditions. The mean arterial oxygen saturation during the final 30 minutes of each approximately 3-hour condition will be compared across intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Expected values for mean arterial oxygen saturation in post-operative cardiac surgery patients with congenital heart disease range from 60% to > 95%.
Measured: The time frame for the mean arterial pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change in Central Venous Pressure Across Three Pacing Conditions
Central venous pressure is the pressure measured in the central veins returning blood to the heart. Central venous pressure will be monitored as part of routine postoperative care. The mean central venous pressure during the final 30 minutes of each approximately 3-hour condition will be compared across intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Central venous pressure is highly dependent on the type of congenital heart disease repaired and will be compared to patients with similar physiology. Across a range of physiologic states, values are typically between 3 mmHg and 25 mmHg.
Measured: The time frame for the mean central venous pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change in Mean Airway Pressure Across Three Pacing Conditions
Mean airway pressure is the average pressure in the airways during a respiratory cycle. It will be recorded when available as part of routine postoperative care. The mean airway pressure during the final 30 minutes of each approximately 3-hour condition will be compared across intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Normal values are between 5-10 cmH₂O for our participant population.
Measured: The time frame for the mean airway pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change in Serum Lactate Concentration During the First 72 Hours After Surgery
Serum lactate concentration will be obtained from laboratory testing performed as part of routine postoperative clinical care. Lactate values and their corresponding collection times will be recorded and used to evaluate changes in lactate concentration following surgery and in relation to the study pacing conditions. No additional blood samples are required for the study. Expected values are lower than 10 mmol/L for most patients during recovery, although higher values are possible during marginal physiologic states. There is no meaningful interpretation of a low lactate level during surgical recovery and a level below the threshold of assay detection will be interpreted as a normal value.
Measured: The time frame for the serum lactate concentration will be from initiation of the baseline observation period through 72 hours after CICU admission.
Change in Arterial pH During the First 72 Hours After Surgery
Arterial pH measures the acidity or alkalinity of arterial blood. Arterial pH values obtained from blood gas testing performed as part of routine postoperative clinical care will be recorded with their corresponding collection times. Changes in arterial pH will be evaluated during the postoperative period in relation to the study pacing conditions. No additional blood samples are required for the study. While physiologic values between 7.35 and 7.45 are target values, we anticipate that patients will transiently have values between 7.2 and 7.35. Values lower than 7.2 will be evaluated by our clinical team. It is unusual to have significant non-iatrogenic alkalosis in the post-surgical state.
Measured: The time frame for the arterial pH will be from initiation of the baseline observation period through 72 hours after CICU admission.
Change in Arterial Bicarbonate Concentration During the First 72 Hours After Surgery
Arterial bicarbonate concentration is a measure obtained from arterial blood gas testing that provides information about the body's acid-base balance. Bicarbonate values obtained as part of routine postoperative clinical care will be recorded with their corresponding collection times. Changes in arterial bicarbonate concentration will be evaluated during the postoperative period in relation to the study pacing conditions. No additional blood samples are required for the study. We expected values between 21-27 mmol/L for our participant population.
Measured: The time frame for the arterial bicarbonate concentration will be from initiation of the baseline observation period through 72 hours after CICU admission.
Change in Intrinsic Heart Rate Across Three Pacing Conditions
Intrinsic heart rate is the participant's natural heart rate without protocol-directed atrial pacing. Heart rate will be continuously monitored during each study condition. Intrinsic heart rate measurements will be used to characterize the participant's underlying heart rate during the pacing phases and to evaluate changes associated with the different pacing conditions. Normal values are between 100-180 bpm for our participant population.
Measured: The time frame for the intrinsic heart rate will be during the final 15 minutes of each approximately 3-hour pacing conditions.
Pacing Capture Thresholds and Derived Rheobase and Chronaxie During the First 72 Hours After Surgery
Pacing capture thresholds are the minimum electrical stimulus strengths required to consistently capture the heart and will be measured across multiple pulse durations using temporary epicardial pacing wires and routine temporary pacing equipment. These measurements will be used to construct postoperative strength-duration curves and derive rheobase and chronaxie, which describe the electrical stimulus characteristics required for cardiac capture. Measurements will be obtained at baseline and daily through postoperative day 3 to evaluate changes in pacing requirements and electrophysiologic properties over the postoperative period.
Measured: The time line will be at baseline and postoperative days 1, 2, and 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pacing TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are divided into two prespecified physiologic groups based on single-ventricle versus two-ventricle circulation. Within each group, participants are randomized to one of two sequences of the same three study conditions: intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Thus, all participants receive the same three conditions, but the order and timing of the conditions differ according to the assigned sequence, allowing each participant to serve as their own control.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert G. Webster, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Sponsor-investigator, Robert G. Webster, MD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Robert G Webster, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852390
- Sponsor's protocol ID
- STUDY00001292
- Acronym
- POSTPACE
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are happy to provide aggregate data, but with N\<50 and complex congenital heart disease (which tends to be highly unique in description), providing individual-level data from a single-center study is a potential risk for re-identification.
Publications
Kielbasa G, Jastrzebski M, Bednarek A, Kusiak A, Sondej T, Bednarski A, Ostrowska A, Zydzik L, Rajzer M, Vijayaraman P, Moskal P. Strength-duration curves for left bundle branch area pacing. Heart Rhythm. 2024 Nov;21(11):2262-2269. doi: 10.1016/j.hrthm.2024.05.026. Epub 2024 May 15.
PubMed 38759916Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Vijayaraman P, Czarnecka D. His bundle has a shorter chronaxie than does the adjacent ventricular myocardium: Implications for pacemaker programming. Heart Rhythm. 2019 Dec;16(12):1808-1816. doi: 10.1016/j.hrthm.2019.06.001. Epub 2019 Jun 8.
PubMed 31181375Coates S, Thwaites B. The strength-duration curve and its importance in pacing efficiency: a study of 325 pacing leads in 229 patients. Pacing Clin Electrophysiol. 2000 Aug;23(8):1273-7. doi: 10.1111/j.1540-8159.2000.tb00943.x.
PubMed 10962751Barold SS, Winner JA. Techniques and significance of threshold measurement for cardiac pacing. Relationship to output circuit of cardiac pacemakers. Chest. 1976 Dec;70(6):760-6. doi: 10.1378/chest.70.6.760.
PubMed 1001053Barold SS, Ong LS, Heinle RA. Stimulation and sensing thresholds for cardiac pacing: electrophysiologic and technical aspects. Prog Cardiovasc Dis. 1981 Jul-Aug;24(1):1-24. doi: 10.1016/0033-0620(81)90025-6. No abstract available.
PubMed 7019961Gaies MG, Gurney JG, Yen AH, Napoli ML, Gajarski RJ, Ohye RG, Charpie JR, Hirsch JC. Vasoactive-inotropic score as a predictor of morbidity and mortality in infants after cardiopulmonary bypass. Pediatr Crit Care Med. 2010 Mar;11(2):234-8. doi: 10.1097/PCC.0b013e3181b806fc.
PubMed 19794327Zaleski KL, Kussman BD. Near-Infrared Spectroscopy in Pediatric Congenital Heart Disease. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):489-500. doi: 10.1053/j.jvca.2019.08.048. Epub 2019 Sep 3.
PubMed 31582201Owens GE, King K, Gurney JG, Charpie JR. Low renal oximetry correlates with acute kidney injury after infant cardiac surgery. Pediatr Cardiol. 2011 Feb;32(2):183-8. doi: 10.1007/s00246-010-9839-x. Epub 2010 Nov 19.
PubMed 21085945Niezen CK, Modestini M, Massari D, Bos AF, Scheeren TWL, Struys MMRF, Vos JJ. Prognostic Value of Perioperative Near-Infrared Spectroscopy Monitoring for Postoperative Acute Kidney Injury in Pediatric Cardiac Surgery: A Systematic Review. Semin Cardiothorac Vasc Anesth. 2025 Sep;29(3):209-218. doi: 10.1177/10892532251316682. Epub 2025 Feb 10.
PubMed 39928846Ergul Y, Unsal S, Ozyilmaz I, Ozturk E, Carus H, Guzeltas A. Electrocardiographic and electrophysiologic effects of dexmedetomidine on children. Pacing Clin Electrophysiol. 2015 Jun;38(6):682-7. doi: 10.1111/pace.12623. Epub 2015 Apr 11.
PubMed 25753681Wang Q, Chen C, Wang L. Efficacy and safety of dexmedetomidine in maintaining hemodynamic stability in pediatric cardiac surgery: a systematic review and meta-analysis. J Pediatr (Rio J). 2022 Jan-Feb;98(1):15-25. doi: 10.1016/j.jped.2021.05.008. Epub 2021 Jul 9.
PubMed 34252370Mendel B, Christianto C, Setiawan M, Prakoso R, Siagian SN. A Comparative Effectiveness Systematic Review and Meta-analysis of Drugs for the Prophylaxis of Junctional Ectopic Tachycardia. Curr Cardiol Rev. 2022;18(1):e030621193817. doi: 10.2174/1573403X17666210603113430.
PubMed 34082685Loomba RS, Villarreal EG, Farias JS, Flores S, Wong J. Factors associated with renal oxygen extraction in mechanically ventilated children after the Norwood operation: insights from high fidelity haemodynamic data. Cardiol Young. 2024 May 24:1-6. doi: 10.1017/S1047951124025174. Online ahead of print.
PubMed 38783789Chauhan M, Prentice E, Zidan M, Walters HL 3rd, Delius RE, Mastropietro CW. Necessity of temporary epicardial pacing wires after surgery for congenital heart disease. Ann Thorac Surg. 2014 Jun;97(6):2148-53. doi: 10.1016/j.athoracsur.2014.02.020. Epub 2014 Mar 28.
PubMed 24681035Barker GM, Affolter J, Saenz J, Cox CS, Forbess JM, Scott WA, Zeltser I. Temporary atrial pacing for cardiac output after pediatric cardiac surgery. Pediatr Cardiol. 2013 Oct;34(7):1605-11. doi: 10.1007/s00246-013-0687-3. Epub 2013 Mar 16.
PubMed 23503930
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pacing for Cardiac Efficiency
- ClinicalTrials.gov ID
- NCT07852390
- Acronym / sponsor ID
- POSTPACE / STUDY00001292
- Conditions
- Pacing Therapy, Postoperative Care, Pediatric Congenital Heart Surgery, Cardiac Pacing, Postoperative Cardiac Surgery
- Keywords
- Renal NIRS, Postoperative cardiac pacing, Pediatric cardiac surgery, Postoperative care, Atrial pacing, Pediatric cardiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Robert G. Webster, MD, MPHUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are divided into two prespecified physiologic groups based on single-ventricle versus two-ventricle circulation. Within each group, participants are randomized to one of two sequences of the same three study conditions: intrinsic sinus rhythm, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. Thus, all participants receive the same three conditions, but the order and timing of the conditions differ according to the assigned sequence, allowing each participant to serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Group 1: No pacing, +20 bpm, +10 bpm | Experimental | Other: Temporary Atrial PacingParticipants 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. |
| Group 2: +20 bpm, +10 bpm, no pacing | Experimental | Other: Temporary Atrial PacingParticipants 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. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary Atrial PacingTemporary 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. | Other | Group 1: No pacing, +20 bpm, +10 bpm, Group 2: +20 bpm, +10 bpm, no pacing |
Primary outcome
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.
Renal near-infrared spectroscopy (NIRS) is a noninvasive monitor that estimates the amount of oxygen in blood within the tissues of the kidney. Renal NIRS will be continuously measured during each of the three study conditions: intrinsic sinus rhythm without protocol-directed pacing, atrial pacing at 10 beats per minute above the intrinsic sinus rate, and atrial pacing at 20 beats per minute above the intrinsic sinus rate. The mean renal NIRS value during the final 30 minutes of each approximately 3-hour condition will be used for analysis. The primary outcome will assess the change in mean renal NIRS across the three pacing conditions, with each participant serving as their own control. Expected values for renal NIRS in post-operative cardiac surgery patients with congenital heart disease range from 45% to > 95%.
10 secondary outcomes
Change in Cerebral NIRS Across Three Pacing Conditions
Time frame: The time frame for the cerebral NIRS will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change Mean Arterial Pressure Across Three Pacing Conditions
Time frame: The time frame for the mean arterial pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change in Mean Arterial Oxygen Saturation Across Three Pacing Conditions
Time frame: The time frame for the mean arterial pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change in Central Venous Pressure Across Three Pacing Conditions
Time frame: The time frame for the mean central venous pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change in Mean Airway Pressure Across Three Pacing Conditions
Time frame: The time frame for the mean airway pressure will be during the final 30 minutes of each of the approximately 3-hour pacing conditions.
Change in Serum Lactate Concentration During the First 72 Hours After Surgery
Time frame: The time frame for the serum lactate concentration will be from initiation of the baseline observation period through 72 hours after CICU admission.
Change in Arterial pH During the First 72 Hours After Surgery
Time frame: The time frame for the arterial pH will be from initiation of the baseline observation period through 72 hours after CICU admission.
Change in Arterial Bicarbonate Concentration During the First 72 Hours After Surgery
Time frame: The time frame for the arterial bicarbonate concentration will be from initiation of the baseline observation period through 72 hours after CICU admission.
Change in Intrinsic Heart Rate Across Three Pacing Conditions
Time frame: The time frame for the intrinsic heart rate will be during the final 15 minutes of each approximately 3-hour pacing conditions.
Pacing Capture Thresholds and Derived Rheobase and Chronaxie During the First 72 Hours After Surgery
Time frame: The time line will be at baseline and postoperative days 1, 2, and 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 38759916Kielbasa G, Jastrzebski M, Bednarek A, Kusiak A, Sondej T, Bednarski A, Ostrowska A, Zydzik L, Rajzer M, Vijayaraman P, Moskal P. Strength-duration curves for left bundle branch area pacing. Heart Rhythm. 2024 Nov;21(11):2262-2269. doi: 10.1016/j.hrthm.2024.05.026. Epub 2024 May 15.
- Background: PubMed 31181375Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Vijayaraman P, Czarnecka D. His bundle has a shorter chronaxie than does the adjacent ventricular myocardium: Implications for pacemaker programming. Heart Rhythm. 2019 Dec;16(12):1808-1816. doi: 10.1016/j.hrthm.2019.06.001. Epub 2019 Jun 8.
- Background: PubMed 10962751Coates S, Thwaites B. The strength-duration curve and its importance in pacing efficiency: a study of 325 pacing leads in 229 patients. Pacing Clin Electrophysiol. 2000 Aug;23(8):1273-7. doi: 10.1111/j.1540-8159.2000.tb00943.x.
- Background: PubMed 1001053Barold SS, Winner JA. Techniques and significance of threshold measurement for cardiac pacing. Relationship to output circuit of cardiac pacemakers. Chest. 1976 Dec;70(6):760-6. doi: 10.1378/chest.70.6.760.
- Background: PubMed 7019961Barold SS, Ong LS, Heinle RA. Stimulation and sensing thresholds for cardiac pacing: electrophysiologic and technical aspects. Prog Cardiovasc Dis. 1981 Jul-Aug;24(1):1-24. doi: 10.1016/0033-0620(81)90025-6. No abstract available.
- Background: PubMed 19794327Gaies MG, Gurney JG, Yen AH, Napoli ML, Gajarski RJ, Ohye RG, Charpie JR, Hirsch JC. Vasoactive-inotropic score as a predictor of morbidity and mortality in infants after cardiopulmonary bypass. Pediatr Crit Care Med. 2010 Mar;11(2):234-8. doi: 10.1097/PCC.0b013e3181b806fc.
- Background: PubMed 31582201Zaleski KL, Kussman BD. Near-Infrared Spectroscopy in Pediatric Congenital Heart Disease. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):489-500. doi: 10.1053/j.jvca.2019.08.048. Epub 2019 Sep 3.
- Background: PubMed 21085945Owens GE, King K, Gurney JG, Charpie JR. Low renal oximetry correlates with acute kidney injury after infant cardiac surgery. Pediatr Cardiol. 2011 Feb;32(2):183-8. doi: 10.1007/s00246-010-9839-x. Epub 2010 Nov 19.
- Background: PubMed 39928846Niezen CK, Modestini M, Massari D, Bos AF, Scheeren TWL, Struys MMRF, Vos JJ. Prognostic Value of Perioperative Near-Infrared Spectroscopy Monitoring for Postoperative Acute Kidney Injury in Pediatric Cardiac Surgery: A Systematic Review. Semin Cardiothorac Vasc Anesth. 2025 Sep;29(3):209-218. doi: 10.1177/10892532251316682. Epub 2025 Feb 10.
- Background: PubMed 25753681Ergul Y, Unsal S, Ozyilmaz I, Ozturk E, Carus H, Guzeltas A. Electrocardiographic and electrophysiologic effects of dexmedetomidine on children. Pacing Clin Electrophysiol. 2015 Jun;38(6):682-7. doi: 10.1111/pace.12623. Epub 2015 Apr 11.
- Background: PubMed 34252370Wang Q, Chen C, Wang L. Efficacy and safety of dexmedetomidine in maintaining hemodynamic stability in pediatric cardiac surgery: a systematic review and meta-analysis. J Pediatr (Rio J). 2022 Jan-Feb;98(1):15-25. doi: 10.1016/j.jped.2021.05.008. Epub 2021 Jul 9.
- Background: PubMed 34082685Mendel B, Christianto C, Setiawan M, Prakoso R, Siagian SN. A Comparative Effectiveness Systematic Review and Meta-analysis of Drugs for the Prophylaxis of Junctional Ectopic Tachycardia. Curr Cardiol Rev. 2022;18(1):e030621193817. doi: 10.2174/1573403X17666210603113430.
- Individual participant dataSharing planned: No. We are happy to provide aggregate data, but with N<50 and complex congenital heart disease (which tends to be highly unique in description), providing individual-level data from a single-center study is a potential risk for re-identification.
Related trials for Pacing Therapy
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
Bachmann's Bundle Versus Right Atrial Appendage Pacing
Atrial Fibrillation (AF)
Not yet recruitingPhase 3
Optimal PharmacoTherapy and Invasive Management of Atrial Fibrillation in Patients With Heart Failure
Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation (AF)
Recruiting
Novel Setup Algorithm for Cardiac Neuromodulation Therapy
Hypertension, Bradycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert G Webster, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Atrial Pacing in people with Pacing Therapy and Postoperative Care, run by Robert G. Webster, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert G Webster, MD, MPH (312-227-4397, RGWebster@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07852390, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.