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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06384963




Registration number
NCT06384963
Ethics application status
Date submitted
19/04/2024
Date registered
25/04/2024
Date last updated
20/08/2024

Titles & IDs
Public title
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Scientific title
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Secondary ID [1] 0 0
Cer22/02
Universal Trial Number (UTN)
Trial acronym
RSA-PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Reduced Ejection Fraction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Atrial pacing with respiratory sinus arrhythmia (RSA) variability
Treatment: Devices - Monotonic right atrial overdrive pacing

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.


Treatment: Devices: 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.

Treatment: Devices: Monotonic right atrial overdrive pacing
Pacing is delivered by a PACE204 pacemaker (Osypka Medical AG) delivering standard monotonic right atrial pacing
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of arrhythmia episodes per patient during pacing
Timepoint [1] 0 0
Up to 10 days

Eligibility
Key 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
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
22/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ceryx Medical Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06384963
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin Stiles, MB ChB
Address 0 0
Waikato Hospital, Hamilton, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Flora Yuen, BSc
Address 0 0
Country 0 0
Phone 0 0
+61 438 890 650
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06384963