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

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 22

Healthy Volunteers: f

View:

• 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

Locations

Other Locations

United Kingdom

Cardiff & Vale University Health Board

RECRUITING

Cardiff

Contact Information

Primary

Susan Peirce, PhD

susan.peirce@wales.nhs.uk

+44 (0)29 218 44771

Backup

Judith White, PhD

uhw.CEDAR@wales.nhs.uk

+44 (0)29 218 44771

Time Frame

Start Date: 2024-11-22

Estimated Completion Date: 2026-04-01

Participants

Target number of participants: 54

Treatments

Experimental: Atrial pacing with respiratory sinus arrhythmia (RSA) variability

The experimental arm is atrial pacing with additional respiratory sinus arrhythmia (RSA) modulation following coronary artery bypass graft (CABG) surgery. Pacing impulses will be grouped together during inspiration, such that heart rate (HR) will increase by approximately 6 bpm above median during inspiration, and decrease by around 6 bpm below median during expiration. Five pacing rates will be used to accommodate a range of patients' intrinsic HR.~Pacing will be initiated after randomisation, after the patient is removed from ventilator support (Pacing Day 1, PD1). This is usually the day after surgery. Pacing will continue until the patient is ready for discharge or there is a clinical decision to stop pacing and remove the leads (whichever is soonest).~Pacing is delivered by a PACE204 pacemaker (Osypka Medical AG) modulated to respiratory phase by a Ceryx device (intervention)

Active_comparator: Monotonic atrial pacing

The control arm is standard monotonic right atrial pacing at the relevant median rate following coronary artery bypass graft (CABG) surgery. Pacing will be initiated after randomisation, after the patient is removed from ventilator support (Pacing Day 1, PD1). This is usually the day after surgery. Pacing will continue until the patient is ready for discharge or there is a clinical decision to stop pacing and remove the leads (whichever is soonest).~Pacing is delivered by a PACE204 pacemaker (Osypka Medical AG) delivering standard monotonic right atrial pacing.

Related Therapeutic Areas

Heart Failure

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