Actively Recruiting
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Led by Ceryx Medical Australia · Updated on 2025-07-22
54
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
Sponsors
C
Ceryx Medical Australia
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
2
Monash Health
Melbourne, Victoria, Australia, 3800
Actively Recruiting
3
Waikato Hospital
Hamilton, New Zealand, 3240
Actively Recruiting
Research Team
F
Flora Yuen, BSc
CONTACT
M
Melissa Crowne, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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