Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Recruiting · NCT06384963 · Interventional (participants receive a specific treatment) · Lead sponsor: Ceryx Medical Australia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Requirement for concurrent valve replacement surgery.
- Off-pump CABG.
- Emergency CABG
- History of paroxysmal or permanent atrial fibrillation or flutter
- History of atrioventricular-node dependent tachycardia
- Patients lacking capacity to consent
- Patient testing positive for Covid-19 within 14 days of intended CABG (PCR or lateral flow test)
- Intrinsic resting heart rate \> 100bpm
- Pregnancy
- Implanted pacemaker or defibrillator
- Failure to obtain Uscom signals
Where it is running
3 locations listed.
- Waikato Hospital - Hamilton, New Zealand
- Royal Adelaide Hospital - Adelaide, South Australia, Australia
- Monash Health - Melbourne, Victoria, Australia