CompletedNot Applicable

Respiratory Sinus Arrhythmia (RSA) Pacing Post-CABG Surgery in Patients With HFrEF

United Kingdom30 participantsStarted 2024-11-22

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested a type of pacing called RSA pacing after CABG surgery in people with heart failure with reduced ejection fraction — is that a combination that could ever apply to my situation, and what does my doctor think about this approach?
2The trial's main goal was to count how many arrhythmia episodes patients had during RSA pacing — based on what that data might show, does my doctor think RSA pacing has shown enough promise to be worth discussing as part of my care plan?
3Since this trial has already completed, has my doctor seen or heard any results from it, and how might those findings compare to what I could expect from standard treatments I'm already being offered?
4This study was listed as 'Phase NA,' meaning it wasn't a standard drug-testing phase trial — does my doctor know whether this type of pacing is still considered experimental, or is it moving closer to being a recognized treatment option?
5If RSA pacing after CABG surgery did reduce arrhythmia episodes in this trial, is that something my doctor would consider relevant to my specific type of heart failure, and are there other similar studies or options I should know about?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of arrhythmia episodes per patient during pacing

Timeframe: From start of pacing to end of pacing

Trial details

NCT IDNCT06359938

SponsorCeryx Medical Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-31

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction trials