RecruitingNot ApplicableNCT06359938

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

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

Sponsor

Ceryx Medical Ltd

Enrollment

54 participants

Start Date

Nov 22, 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 trial is testing a special type of heart pacing called Respiratory Sinus Arrhythmia (RSA) pacing after coronary artery bypass graft (CABG) surgery in patients with heart failure with reduced ejection fraction (HFrEF). RSA pacing mimics the natural variation in heart rate that happens when you breathe, which may improve heart function. **You may be eligible if...** - You are 22 or older - You are scheduled for a planned (not emergency) CABG (bypass) surgery - You have been diagnosed with heart failure with reduced ejection fraction (HFrEF), meaning your heart pumps at 20–40% of its normal capacity - Your heart is in normal sinus rhythm (not atrial fibrillation) - Your bypass will include the left anterior descending artery **You may NOT be eligible if...** - You also need valve replacement surgery at the same time - You are having off-pump bypass surgery - This is an emergency surgery - You have a history of atrial fibrillation, flutter, or prior ablation - You have a pacemaker or implantable defibrillator already 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

Locations(1)

Cardiff & Vale University Health Board

Cardiff, United Kingdom

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NCT06359938

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