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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Atrial pacing with respiratory sinus arrhythmia (RSA) variability

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. A pacemaker (PACE204, Osypka Medical AG), similar to those currently in common use in post-CABG patients, will be adapted to receive an additional input signal based on the respiratory signal (Ceryx device). The respiration signal will be combined with the ECG signal to determine the appropriate pacing interval. The pacing impulse will be delivered by the pacemaker unit.

DEVICE

Monotonic right atrial overdrive pacing

Pacing is delivered by a PACE204 pacemaker (Osypka Medical AG) delivering standard monotonic right atrial pacing

Locations (3)

Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health
Melbourne, Victoria, Australia
Waikato Hospital
Hamilton, New Zealand