Actively Recruiting
Respiratory Sinus Arrhythmia (RSA) Pacing Post-CABG Surgery in Patients With HFrEF
Led by Ceryx Medical Ltd · Updated on 2024-12-13
54
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
C
Ceryx Medical Ltd
Lead Sponsor
C
Cardiff and Vale University Health Board
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Respiratory Sinus Arrhythmia (RSA) Pacing Post-CABG Surgery in Patients With HFrEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 showing left ventricular ejection fraction of 20%-40% within 1 month before surgery
- Sinus rhythm
- Coronary vessel replacement including left anterior descending artery
- Able to provide written informed consent
You will not qualify if you...
- Need for valve replacement surgery at the same time
- Off-pump CABG surgery
- Emergency CABG surgery
- History of paroxysmal or permanent atrial fibrillation or flutter
- History of atrioventricular-node dependent tachycardia
- Unable to provide informed consent
- Positive Covid-19 test within 14 days before surgery
- Resting heart rate over 100 bpm
- Pregnancy
- Implanted pacemaker or defibrillator
- Failure to obtain Uscom signals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cardiff & Vale University Health Board
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
Research Team
S
Susan Peirce, PhD
CONTACT
J
Judith White, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here