NCT06384963 Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
| NCT ID | NCT06384963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ceryx Medical Australia |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2024-09-02 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Martin Stiles, MB ChB
PRINCIPAL INVESTIGATOR
Waikato Hospital, Hamilton, New Zealand
Frequently Asked Questions
Who can join the NCT06384963 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06384963 currently recruiting?
Yes, NCT06384963 is actively recruiting participants. Contact the research team at flora.yuen@avaniaclinical.com for enrollment information.
Where is the NCT06384963 trial being conducted?
This trial is being conducted at Adelaide, Australia, Melbourne, Australia, Hamilton, New Zealand.
Who is sponsoring the NCT06384963 clinical trial?
NCT06384963 is sponsored by Ceryx Medical Australia. The principal investigator is Martin Stiles, MB ChB at Waikato Hospital, Hamilton, New Zealand. The trial plans to enroll 54 participants.
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