Short-Term Atrial Pacing and Hemodynamics After Cardiac Surgery

NCT07082283 | Recruiting

• 1 other identifier: CEHDF-2702
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Cardiac Output

Keywords

Cardiopulmonary bypass; Temporary atrial pacing; Pacing frequency; Hemodynamic profile; Cardiac output

Outcome Measures

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.

  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.

  24 hours after the surgery

Secondary Outcomes (6)

• 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

  24 hours after the surgery

• 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

  24 hours after the surgery

• 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

  24 hours after the surgery

• 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

  24 hours after the surgery

• 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

  24 hours after the surgery

Study Arms (2)

Pacing Group

PLACEBO COMPARATOR

Patients in this group receive continuous atrial pacing at 90 bpm during the first 24 postoperative hours (outside of evaluation sequences).

Procedure: Pacing Protocol for Pacing Group

Non-Pacing Group

ACTIVE COMPARATOR

Patients in this group remain in their spontaneous sinus rhythm outside of the evaluation sequences.

Procedure: Pacing Protocol for Non-pacing Group

Interventions

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 Group

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.

Non-Pacing Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

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

Beirut, Lebanon

RECRUITING

Study Officials

• Samia Jebara

  Saint Joseph University of Beirut

  STUDY CHAIR

Central Study Contacts

Rhea Mattar

CONTACT

+96171464840; rhea.mattar@net.usj.edu.lb

Joanna Tohme

CONTACT

+96170492735; joanna.tohme1@usj.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: Prospective, randomized, controlled, comparative, single-center study

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)