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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— RSA-PACE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384963
• Other study ID #: Cer22/02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: Ceryx Medical Ltd
• Contact: Flora Yuen, BSc
• Phone: +61 438 890 650
• Email: flora.yuen[@]avaniaclinical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a first-in-human (FIH) clinical investigation of a modification of an existing medical device. It will be a comparative, multicentre, randomised controlled trial (RCT) design. RSA modulated atrial pacing will be compared against monotonic atrial pacing in patients with HFrEF who have had CABG surgery.

The purpose of this clinical investigation is to explore the risk/benefit profile of the use of RSA pacing in patients with HFrEF following CABG. Based on the prior animal models the investigators hypothesise an improvement in cardiac function over several days of RSA pacing, with no increase in risk compared to typical pacemaker use.

Primary hypothesis - Atrial pacing with additional RSA variability (for up to 10 days) is feasible and safe in patients with heart failure and reduced ejection fraction. The primary outcome is measuring arrhythmia episodes.

Secondary hypothesis - Atrial pacing with additional RSA variability improves cardiac function in patients with heart failure and reduced ejection fraction following CABG surgery. The secondary outcomes is measuring cardiac function, cardiac output, apnoea episodes.

Respiratory sinus arrhythmia is part of normal physiology and RSA pacing is looking to restore this. In heart failure, RSA is severely reduced. Therefore the investigators have identified that, post-CABG surgery patients with heart failure and reduced ejection fraction are the ideal candidates for this study. Following surgery it is standard of care for a surgeon to leave temporary pacing wires attached to the heart as a precaution and it is not uncommon to leave them in for 10 days or longer. Hence, these temporary wires can be used to deliver RSA pacing. Adjusting pacing rates is common in both implanted or temporary pacemakers.

Potential patients awaiting CABG surgery with heart failure with reduced ejection fraction will be identified using two routes - inpatients and outpatients.

The investigators would randomly allocate patients to either the RSA external pacemaker box or the normal external pacemaker for a maximum of 10 days. Patients will be connected to nasal prongs to monitor their respiration and in the RSA group, this signal will be fed to the external pacemaker to deliver RSA pacing.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: April 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Arrhythmia, Sinus
• Arrhythmias, Cardiac
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Device:
• Atrial 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.
• Monotonic right atrial overdrive pacing
Pacing is delivered by a PACE204 pacemaker (Osypka Medical AG) delivering standard monotonic right atrial pacing

Locations

Country	Name	City	State
New Zealand	Waikato Hospital	Hamilton

Sponsors (2)

Lead Sponsor	Collaborator
Ceryx Medical Australia	Avania

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 10 days