Tests a new pacemaker after bypass surgery in heart failure patients
Tests a breathing-linked pacemaker in heart failure patients after bypass surgery.
Plain-language title generated from the registry record
Registry title: Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Key facts
- Where
- Adelaide and Melbourne, AustraliaSee the 2 sites
Where in Australia
- Royal Adelaide HospitalAdelaide, AustraliaTaking people
- Monash HealthMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ceryx Medical Australia
- Trial code
- NCT06384963
- Record updated
- 22 July 2025
- Original description
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.Read full original descriptionShow less
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
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.
Inclusion: Adult patients (≥ 22 years) selected for isolated, on-pump coronary artery bypass graft (CABG); Established diagnosis of heart failure with reduced ejection fraction (HFrEF); Elective or urgent admission routes; Echocardiography assessment of left ventricular ejection fraction (EF) of 20%-40% (within 1 month of planned surgery); Sinus rhythm; Any number of coronary vessels replaced. Must include left anterior descending artery; Able to provide written informed consent.
Exclusion: Requirement for concurrent valve replacement surgery; History of paroxysmal or permanent atrial fibrillation or flutter; History of atrioventricular-node dependent tachycardia; Patient testing positive for Covid-19 within 14 days of intended CABG (PCR or lateral flow test); Intrinsic resting heart rate > 100bpm; Failure to obtain Uscom signals; Off-pump CABG; Emergency CABG; Patients lacking capacity to consent; Pregnancy; Implanted pacemaker or defibrillator.