Short-term atrial pacing after heart surgery to support heart output
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
This trial tests whether temporarily pacing the atrium at 70, 80, or 90 beats per minute after cardiopulmonary bypass heart surgery improves cardiac output and lowers the chance of postoperative atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint-Joseph University Academic / other |
| Locations | 1 site (Beirut) |
| Trial ID | NCT07082283 on ClinicalTrials.gov |
What this trial studies
Adults having cardiac surgery with cardiopulmonary bypass who receive epicardial atrial pacing wires and a Swan-Ganz catheter will be managed with either temporary atrial pacing or a non-pacing protocol in the first 24 hours after surgery. Cardiac output will be measured invasively via the Swan-Ganz catheter while patients in the pacing arm are assigned a pacing rate of 70, 80, or 90 bpm to determine which rate maximizes cardiac output. The study will also track incidence of postoperative atrial fibrillation and hemodynamic stability across groups. Data collection focuses on short-term hemodynamics and rhythm outcomes immediately after weaning from bypass.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing planned cardiac surgery with cardiopulmonary bypass who have epicardial atrial pacing wires and a Swan-Ganz catheter placed and can provide informed consent.
Not a fit: Patients with permanent atrial fibrillation, existing internal pacemakers, complete AV block, junctional rhythm, inability to pace the atrium, or significant postoperative hemodynamic instability are unlikely to benefit from the pacing strategies tested.
Why it matters
Potential benefit: If successful, this approach could raise postoperative cardiac output and reduce atrial fibrillation, potentially improving recovery and reducing complications after cardiac surgery.
How similar studies have performed: Atrial pacing has been used for decades and some studies suggest it can reduce rhythm instability, but direct comparisons of specific postoperative pacing rates (70, 80, 90 bpm) are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Beirut
- Department of Anesthesia and Critical Care, Hôtel-Dieu de France Hospital — Beirut, Lebanon (Recruiting)
Study contacts
- Study coordinator: Rhea Mattar
- Email: rhea.mattar@net.usj.edu.lb
- Phone: +96171464840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.