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

Plain Language Summary

Simplified for easier understanding

This study is testing a pacing technique called Respiratory Sinus Arrhythmia (RSA) pacing — which synchronizes the heart rate with breathing — after coronary artery bypass graft (CABG) surgery in people with heart failure with reduced ejection fraction (when the heart pumps less blood than it should). **You may be eligible if...** - You are 22 or older - You have been diagnosed with heart failure with reduced ejection fraction (ejection fraction 20–40%) - You are scheduled for coronary bypass surgery (CABG) including the left anterior descending artery - You are in a normal heart rhythm (sinus rhythm) **You may NOT be eligible if...** - You need valve replacement surgery at the same time - You have had atrial fibrillation or flutter - You have an existing pacemaker or defibrillator - You are pregnant - Your surgery is an emergency - You have tested positive for COVID-19 within 14 days of surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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