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

NCT06359938 | Recruiting DMC

• 1 other identifier: Cer22/01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

heart failure; respiratory sinus arrhythmia; pacemaker

Outcome Measures

Primary Outcomes (1)

• Number of arrhythmia episodes per patient during pacing

  Any episode of arrhythmia, captured on an ECG between the initiation of pacing (Pacing Day 1) and the post-pacing visit (Day 7 - Post-discharge form hospital ), and lasting 30 seconds or longer, will be recorded. Anonymised ECG extracts will be reviewed by two cardiologists to identify the type of arrhythmia.

  From start of pacing to end of pacing

Study Arms (2)

Atrial pacing with respiratory sinus arrhythmia (RSA) variability

EXPERIMENTAL

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)

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

Monotonic atrial pacing

ACTIVE COMPARATOR

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.

Device: Monotonic right atrial overdrive pacing

Interventions

Atrial pacing with respiratory sinus arrhythmia (RSA) variability DEVICE

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.

Also known as: Modified temporary external pacemaker (Osypka) with additional pacing RSA module (Ceryx box)

Atrial pacing with respiratory sinus arrhythmia (RSA) variability

Monotonic right atrial overdrive pacing DEVICE

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

Also known as: PACE204 pacemaker (Osypka Medical AG) delivering standard monotonic right atrial pacing

Monotonic atrial pacing

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ceryx Medical Ltd: lead
• Cardiff and Vale University Health Board: collaborator

Study Sites (1)

Cardiff & Vale University Health Board

Cardiff, CF14 4XW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure; Arrhythmia, Sinus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zaheer Yousef

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Peirce, PhD

CONTACT

+44 (0)29 218 44771; susan.peirce@wales.nhs.uk

Judith White, PhD

CONTACT

+44 (0)29 218 44771; uhw.CEDAR@wales.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 11, 2024
• Study Start: November 22, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

GB (1)