Can a Breathing-Synchronized pacemaker boost heart function after bypass?
NCT ID NCT06359938
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial tests a new type of pacemaker for people with heart failure who are having coronary bypass surgery. The pacemaker is designed to mimic a natural pattern called respiratory sinus arrhythmia, where the heart rate speeds up when breathing in and slows down when breathing out. The study aims to see if this pacing approach is safe and whether it improves how well the heart pumps blood compared to standard pacing. Participants will be monitored closely during their hospital recovery and receive a follow-up call one month after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A modified temporary external pacemaker that adjusts heart rate with breathing (respiratory sinus arrhythmia pacing)
- What this could lead to
- If it works, this pacing approach could improve heart output and recovery after bypass surgery in heart failure patients, potentially leading to a new standard of care.
- What could go wrong
- This is a small early-stage trial focused on safety and short-term effects, so benefits are uncertain. The pacemaker is temporary and only used during hospital recovery, and it may not improve long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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30 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cardiff & Vale University Health Board
Cardiff, Cardiff, CF14 4XW, United Kingdom
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