Actively Recruiting
Short-Term Atrial Pacing and Hemodynamics After Cardiac Surgery A Prospective Randomized Evaluation of Variable-Rate Atrial Stimulation After Cardiac Surgery With Cardiopulmonary Bypass
Led by Saint-Joseph University · Updated on 2025-08-17
200
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether temporary atrial pacing improves heart function after cardiac surgery using cardiopulmonary bypass (CPB). The trial focuses on whether atrial pacing enhances cardiac output, identifies the most effective pacing rate (70, 80, or 90 bpm), and examines if pacing lowers the risk of atrial fibrillation post-surgery. This evaluation is important as postoperative rhythm issues and reduced heart function frequently occur after such surgeries. Participants receive either continuous atrial pacing at 90 bpm or remain in their natural sinus rhythm during the first 24 hours after surgery. At four specific times (arrival in ICU, 6, 12, and 24 hours post-surgery), transient pacing sequences at different rates (70, 80, and 90 bpm) are applied briefly for 10 minutes each to measure heart function. This procedure is done in both groups to compare the effects of pacing and rate variations. During the study, participants are monitored using Swan-Ganz catheters to measure cardiac index and other heart function parameters at regular intervals within the first 24 hours post-surgery. Researchers also assess blood pressure, stroke volume, vascular resistance, and ventricular work. The study aims to determine the best pacing rate and whether pacing reduces atrial fibrillation risk, with careful safety monitoring throughout the postoperative period.
CONDITIONS
Brief Title
Short-Term Atrial Pacing and Hemodynamics After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Undergoing cardiac surgery under cardiopulmonary bypass, including 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 during surgery
- Signed informed consent
You will not qualify if you...
- Emergency surgery
- Having an internal pacemaker
- History of permanent atrial fibrillation
- Complete atrioventricular block upon weaning from cardiopulmonary bypass
- Junctional rhythm upon weaning from cardiopulmonary bypass
- Sinus rhythm less than 50 bpm upon weaning from cardiopulmonary bypass
- Failure of atrial or dual-chamber pacing (paced in ventricular mode VVI)
- Contraindication to Swan-Ganz catheter placement
- Hemodynamic instability defined by significant bleeding, tamponade requiring surgery, or need for high doses of vasopressors (Norepinephrine > 1 mcg/kg/min, Dobutamine > 10 mcg/kg/min)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants undergo cardiac surgery under cardiopulmonary bypass with placement of epicardial atrioventricular pacing wires and a Swan-Ganz catheter during surgery.
1 hospital stay including surgery and post-operative monitoring
Duration - 24 hours post-surgery
For the first 24 hours after surgery, participants receive either continuous atrial pacing at 90 bpm (pacing group) or remain in their spontaneous sinus rhythm (non-pacing group). At four standardized time points (arrival in ICU, 6, 12, and 24 hours post-surgery), transient pacing sequences at 70, 80, and 90 bpm are applied for measurements of hemodynamic profiles and blood pressure.
4 monitoring sessions at H0, H6, H12, and H24 during hospital stay
Duration - Up to hospital discharge
Participants are observed for cardiac rhythm stability and hemodynamic outcomes after the 24-hour pacing period.
Additional assessments during hospitalization as needed
Trial Site Locations
Total: 1 location
1
Department of Anesthesia and Critical Care, Hôtel-Dieu de France Hospital
Beirut, Lebanon
Actively Recruiting
Research Team
R
Rhea Mattar
J
Joanna Tohme
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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