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Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF

Study acronym: RSA-PACE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 22, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Aug 22, 2024 to Sep 2, 2024
    v3
  2. Primary completion date: Mar 1, 2025 to Mar 1, 2026
    • Start date: Jun 1, 2024 to Aug 22, 2024
    • Study completion date: Apr 1, 2025 to Apr 1, 2026
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out. The main questions the trial aims to answer are: * Is the new type of pacemaker safe? * Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)? Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients.
Trial Details
NCT Number NCT06384963
Lead Sponsor Ceryx Medical Australia
Collaborators: Avania
Conditions
(from sponsor)		 Heart Failure With Reduced Ejection Fraction
Related terms Arrhythmia, Sinus, Heart Failure
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov