NCT06384963Recruiting
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Source: ClinicalTrials.gov · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 19 Apr 2024
- Start date
- 2 Sept 2024
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Ceryx Medical Australia
- Diseases
- Heart failure
- NCT number
- NCT06384963
What you commit to
- Study type: Interventional
- Planned participants: 54
- From 2 Sept 2024 to the primary completion date, 1 Mar 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement for concurrent valve replacement surgery.
Other illness
- 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
Other
- Off-pump CABG.
- Emergency CABG
- Patients lacking capacity to consent
- Pregnancy
- Implanted pacemaker or defibrillator
Who the study is looking for
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Monash Health Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Waikato Hospital Coordinator of this site? Confirm its status | Hamilton | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.