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.
Study details:
This is a first-in-human (FIH) clinical investigation of a modification of an existing medical device. It will be a comparative, multicentre, randomised controlled trial (RCT) design. RSA modulated atrial pacing will be compared against monotonic atrial pacing in patients with HFrEF who have had CABG surgery.
The purpose of this clinical investigation is to explore the risk/benefit profile of the use of RSA pacing in patients with HFrEF following CABG. Based on the prior animal models the investigators hypothesise an improvement in cardiac function over several days of RSA pacing, with no increase in risk compared to typical pacemaker use. Primary hypothesis - Atrial pacing with additional RSA variability (for up to 10 days) is feasible and safe in patients with heart failure and reduced ejection fraction.
The primary outcome is measuring arrhythmia episodes. Secondary hypothesis - Atrial pacing with additional RSA variability improves cardiac function in patients with heart failure and reduced ejection fraction following CABG surgery. The secondary outcomes is measuring cardiac function, cardiac output, apnoea episodes.
Respiratory sinus arrhythmia is part of normal physiology and RSA pacing is looking to restore this. In heart failure, RSA is severely reduced. Therefore the investigators have identified that, post-CABG surgery patients with heart failure and reduced ejection fraction are the ideal candidates for this study.
Following surgery it is standard of care for a surgeon to leave temporary pacing wires attached to the heart as a precaution and it is not uncommon to leave them in for 10 days or longer. Hence, these temporary wires can be used to deliver RSA pacing. Adjusting pacing rates is common in both implanted or temporary pacemakers.
Potential patients awaiting CABG surgery with heart failure with reduced ejection fraction will be identified using two routes - inpatients and outpatients. The investigators would randomly allocate patients to either the RSA external pacemaker box or the normal external pacemaker for a maximum of 10 days. Patients will be connected to nasal prongs to monitor their respiration and in the RSA group, this signal will be fed to the external pacemaker to deliver RSA pacing.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT06384963
Intervention or treatment
DEVICE: Atrial pacing with respiratory sinus arrhythmia (RSA) variability
DEVICE: Monotonic right atrial overdrive pacing
Conditions
- Heart Failure With Reduced Ejection Fraction
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Royal Adelaide Hospital
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Ceryx Medical Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Atrial pacing with respiratory sinus arrhythmia (RSA) variability
| Device: Atrial pacing with respiratory sinus arrhythmia (RSA) variability |
ACTIVE_COMPARATOR: Monotonic atrial pacing
| Device: Monotonic right atrial overdrive pacing |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Number of arrhythmia episodes per patient during pacing | Any episode of arrhythmia, captured on an ECG between the initiation of pacing (Pacing Day 1) and the post-pacing visit (Day 7 - Post-discharge form hospital ), and lasting 30 seconds or longer, will be recorded. Anonymised ECG extracts will be reviewed by two cardiologists to identify the type of arrhythmia. | Up to 10 days |
Secondary Outcome
References
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