At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Atrial pacing with respiratory sinus arrhythmia (RSA) variability (device), Monotonic right atrial overdrive pacing (device)
- How long the study runs
- Study runs about 20 months (dates as stated)
- About the drug or intervention
- Atrial pacing with respiratory sinus arrhythmia (RSA) variability — device: The intervention in this study is a modification of the pacing output from a standard external pacemaker such that it will approximate the RSA variation found in healthy subjects. · Monotonic right atrial overdrive pacing — device: Pacing is delivered by a PACE204 pacemaker (Osypka Medical AG) delivering standard monotonic right atrial pacing
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 22 Years and over
- Who
- All
- Number of participants
- 30
- Started
- 2024-11-22
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure with reduced ejection fraction
- • NA - 30 participants
- • The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation
Who can take part?
- • Ages 22 Years and over
- • Diagnosed with heart failure with reduced ejection fraction
Where?
- • Cardiff - Cardiff & Vale University Health Board
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 22 Years and over
- Who can join: All genders
Biomarkers mentioned
What 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
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (1 UK site)
Cardiff & Vale University Health Board
Cardiff CF14 4XW, United Kingdom