Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384963
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-19
Brief Title:
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Sponsor:
Ceryx Medical Australia
Organization:
Ceryx Medical Ltd
Study Overview
Official Title:
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RSA-PACE
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
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
Detailed 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 riskbenefit 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
The purpose of this clinical investigation is to explore the riskbenefit 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None