RecruitingNot ApplicableNCT06384963

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

Sponsor

Ceryx Medical Australia

Enrollment

54 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Reduced Ejection Fraction

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.

Eligibility

Min Age: 22 Years

Inclusion Criteria7

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 Criteria11

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

Interventions

DEVICEAtrial 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.

DEVICEMonotonic right atrial overdrive pacing

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