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NCT Number: NCT07082283

Short-Term Atrial Pacing and Hemodynamics After Cardiac Surgery

The goal of this clinical trial is to learn whether temporary atrial pacing improves heart function after cardiac surgery under cardiopulmonary bypass (CPB). It will also help determine the best pacing rate during the first 24 hours after surgery. The main questions it aims to answer are:

* Does atrial pacing improve cardiac output after surgery? * Is 70, 80, or 90 bpm the most effective pacing rate? * Does pacing reduce the risk of atrial fibrillation after surgery?

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia and Critical Care, Hôtel-Dieu de France Hospital

Beirut, Lebanon

Location status: Recruiting

Location contact

Amine Fikani

SUB_INVESTIGATOR

Joanna Tohme

CONTACT

[email protected]

+96170492735

Joanna Tohme

PRINCIPAL_INVESTIGATOR

Rhea Mattar

CONTACT

[email protected]

+96171464840

Rhea Mattar

PRINCIPAL_INVESTIGATOR

About this study

Cardiac surgery under cardiopulmonary bypass (CPB) frequently leads to immediate postoperative rhythm or conduction disturbances, especially atrial fibrillation or atrioventricular block (AV Block), along with hemodynamic instability and transient reduction in cardiac output due to myocardial contractility impairment.

Temporary pacing wires are placed in the operating room and have been used since the 1960s to manage cardiac conduction disorders in these patients, allowing for atrial (AAI) or dual-chamber (DDD) pacing if necessary. Atrial pacing, by restoring synchronized atrial contraction with ventricular filling, helps maintain optimal cardiac output.

Cardiac output is defined as the product of heart rate (HR) and stroke volume (SV). To optimize cardiac output, increasing heart rate is possible, hence the need for atrial pacing.

A pacing rate slightly higher than spontaneous sinus rhythm appears to prevent pauses, limit rhythm instability, and reduce the risk of atrial fibrillation. However, the optimal pacing rate postoperatively has not been clearly defined, and data comparing different rates (70, 80, or 90 bpm) are scarce.

In our center, postoperative atrial pacing is nearly routine and commonly set at 90 bpm, a rate we consider optimal due to its alignment with the Frank-Starling curve. This rate maximizes venous return and stroke volume, thereby optimizing postoperative cardiac output.

Nevertheless, several studies have suggested that routine postoperative temporary pacing wire insertion may not always be necessary and should be reserved for patients identified as high-risk for postoperative rhythm disturbances.

Nowadays, in many international centers, the absence of routine temporary pacing has become the norm. Although 90 bpm is theoretically the optimal rate for atrial pacing, important questions remain: Is postoperative pacing absolutely necessary? If so, could a rate lower than 90 bpm suffice to maintain adequate hemodynamic profile (HDP)?

This study aims at determining whether routine temporary pacing is necessary during the first 24 hours after cardiac surgery under CPB, and what the optimal pacing rate is (AAI or DDD: 70 bpm vs. 80 bpm vs. 90 bpm) in terms of its impact on the HDP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older
  • Cardiac surgery under CPB (coronary artery bypass grafting, valve replacement or repair, or combined procedures)
  • Placement of epicardial atrioventricular pacing wires during surgery
  • Placement of a Swan-Ganz catheter intraoperatively
  • Signed informed consent

Exclusion criteria

  • Emergency surgery
  • Patients with an internal pacemaker
  • History of permanent atrial fibrillation
  • Complete atrioventricular block upon weaning from CPB
  • Junctional rhythm upon weaning from CPB
  • Sinus rhythm < 50 bpm upon weaning from CPB
  • Failure of atrial or dual-chamber pacing (patients paced in ventricular mode VVI)
  • Contraindication to Swan-Ganz catheter placement
  • Hemodynamic instability defined by significant bleeding or tamponade requiring surgical re-intervention, or the need for escalating doses of vasopressors (Norepinephrine > 1 μg/kg/min, Dobutamine > 10 μg/kg/min)

Treatment and study plan

Pacing Protocol for Pacing Group

Procedure

At four standardized time points (H0: arrival in the ICU, H6, H12, H24), a transient pacing sequence at 70, 80, and 90 bpm is conducted, with each rate applied for 10 minutes to allow stabilization, followed by recording of the hemodynamic profile and blood pressure, as follows:

  • If the patient has a spontaneous rhythm between 50 and 69 bpm, measurements are taken at the spontaneous rate, then at 70 bpm, 80 bpm, and finally 90 bpm
  • If the patient has a spontaneous rhythm between 70 and 79 bpm, measurements are taken at the spontaneous rate, then at 80 bpm, and finally at 90 bpm
  • If the patient has a spontaneous rhythm between 80 and 89 bpm, measurements are taken at the spontaneous rate, then at 90 bpm
  • If the patient has a spontaneous rhythm ≥ 90 bpm, measurements are taken at the spontaneous rate only

Pacing Protocol for Non-pacing Group

Procedure

At H0, H6, H12, and H24, they will undergo transient pacing at 70, 80, and 90 bpm, following the same measurement protocol (10 minutes per rate), followed by recording of the hemodynamic profile and blood pressure, as follows:

  • If the patient has a rhythm between 50 and 69 bpm, measurements will be taken at the spontaneous rate, then at 70 bpm, 80 bpm, and finally 90 bpm
  • If the patient has a rhythm between 70 and 79 bpm, measurements will be taken at the spontaneous rate, then at 80 bpm, and finally at 90 bpm
  • If the patient has a rhythm between 80 and 89 bpm, measurements will be taken at the spontaneous rate, then at 90 bpm
  • If the patient has a rhythm ≥ 90 bpm, measurements will be taken at the spontaneous rate only

Outside the pacing periods at different rates, patients in the non-pacing group will remain on their spontaneous sinus rhythm.

Primary outcomes

  1. Evaluate the impact of different pacing rates on cardiac index measured by Swan-Ganz catheter in the postoperative period following cardiac surgery under cardiopulmonary bypass at H0, H6, H12, and H24.

    Time frame: 24 hours after the surgery

    To evaluate the impact of different pacing rates (50-69 bpm [Category 1], 70-79 bpm [Category 2], 80-89 bpm [Category 3], ≥ 90 bpm [Category 4]) on cardiac index measured by Swan-Ganz catheter in the postoperative period following cardiac surgery under cardiopulmonary bypass (CPB), at H0, H6, H12, and H24.

Secondary outcomes

  1. To determine whether atrial pacing reduces the incidence of atrial fibrillation in the pacing group compared to the non-pacing group in the postoperative period after cardiac surgery under CPB

    Time frame: 24 hours after the surgery

  2. To evaluate the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on cardiac index measured by Swan-Ganz catheter in patients with heart failure following cardiac surgery under CPB

    Time frame: 24 hours after the surgery

  3. To assess the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on mean arterial pressure in the postoperative period after cardiac surgery under CPB

    Time frame: 24 hours after the surgery

  4. To evaluate the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on systemic vascular resistance measured by Swan-Ganz catheter in the postoperative period after cardiac surgery under CPB

    Time frame: 24 hours after the surgery

  5. To assess the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on stroke volume measured by Swan-Ganz catheter in the postoperative period after cardiac surgery under CPB

    Time frame: 24 hours after the surgery

  6. To evaluate the impact of different pacing rates (50-69, 70-79, 80-89, ≥ 90 bpm) on left and right ventricular work measured by Swan-Ganz catheter in the postoperative period after cardiac surgery under CPB

    Time frame: 24 hours after the surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Joanna Tohme

CONTACT

[email protected]

+96170492735

Rhea Mattar

CONTACT

[email protected]

+96171464840

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

STAPH-CS Study: Short-Term Atrial Pacing and Hemodynamics After Cardiac Surgery - A Prospective Randomized Evaluation of Variable-Rate Atrial Stimulation After Cardiac Surgery With Cardiopulmonary Bypass

Acronym: STAPH-CS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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