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NCT06384963

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

Ceryx Medical Australia·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Heart Failure With Reduced Ejection Fraction
Drug/Device/Intervention
Atrial pacing with respiratory sinus arrhythmia (RSA) variability
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Ceryx Medical Australia
Funder
Ceryx Medical Ltd
Location
Hamilton, New Zealand
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Apr 01, 2025
Enrollment
54 participants
Primary outcome

Number of arrhythmia episodes per patient during pacing

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.

ICD-10 classifications
Heart failureCongestive heart failureHeart failure, unspecifiedHypertensive heart disease with (congestive) heart failureLeft ventricular failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06384963
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06384963 through Pure Global AI's free database. This phase not specified trial is sponsored by Ceryx Medical Australia and is currently Not yet recruiting. The study focuses on Heart Failure With Reduced Ejection Fraction. Target enrollment is 54 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.