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Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Sponsor: Ceryx Medical Australia
Summary
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.
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2024-09-02
Completion Date
2026-04-01
Last Updated
2025-07-22
Healthy Volunteers
No
Interventions
Atrial pacing with respiratory sinus arrhythmia (RSA) variability
The intervention in this study is a modification of the pacing output from a standard external pacemaker such that it will approximate the RSA variation found in healthy subjects. A pacemaker (PACE204, Osypka Medical AG), similar to those currently in common use in post-CABG patients, will be adapted to receive an additional input signal based on the respiratory signal (Ceryx device). The respiration signal will be combined with the ECG signal to determine the appropriate pacing interval. The pacing impulse will be delivered by the pacemaker unit.
Monotonic right atrial overdrive pacing
Pacing is delivered by a PACE204 pacemaker (Osypka Medical AG) delivering standard monotonic right atrial pacing
Locations (3)
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health
Melbourne, Victoria, Australia
Waikato Hospital
Hamilton, New Zealand