Respiratory Sinus Arrhythmia (RSA) Pacing Post-CABG Surgery in Patients With HFrEF
This clinical trial is looking at a new type of pacemaker for people with heart failure who have just had heart bypass surgery. The new pacemaker aims to bring back a natural heart rhythm called Respiratory Sinus Arrhythmia (RSA), where your heart speeds up when you breathe in and slows down when you breathe out. In heart failure, this natural rhythm is often lost. Researchers want to find out if this new pacemaker is safe and if it helps improve how well the heart works, compared to the usual heart pacing. Participants will have very close monitoring during their hospital stay and a follow-up call a month later.
At a glance
What is this study about?
This study is testing a new way of using a pacemaker for people who have heart failure with a weakened heart muscle, and have just had heart bypass surgery. Normally, our heart rate changes slightly with our breathing – it speeds up when we breathe in and slows down when we breathe out. This natural rhythm is called Respiratory Sinus Arrhythmia (RSA). When someone has heart failure, this natural breathing-heart rate pattern is often lost or greatly reduced.
The researchers believe that by restoring this natural RSA pattern using a special pacemaker, they might be able to help the heart work better. They will be comparing this new approach to the standard way pacemakers are used after bypass surgery. The main things they want to find out are if this new pacing method is safe, and if it helps improve how well the heart pumps blood around the body.
After heart bypass surgery, it's common for doctors to place temporary wires near the heart. These are usually removed after about 10 days, but in this study, these temporary wires will be used to deliver the new RSA pacing. This means you wouldn’t need another operation to implant a permanent device just for this study.
Key takeaways
- Tests a new temporary pacemaker method for heart failure patients after bypass surgery.
- Aims to restore a natural heart rhythm related to breathing (RSA).
- Compares this new method to standard heart pacing.
- Investigates if it's safe and improves heart function.
- Involves close monitoring during hospital stay and a follow-up call.
- Uses temporary wires, no permanent device implanted for the study.
Who may be eligible?
This study is for adults, aged 22 or older, who are scheduled to have a specific type of heart bypass surgery (called coronary artery bypass graft, or CABG) and also have a diagnosis of heart failure where their heart muscle is weakened (with an ejection fraction between 20% and 40%). You must be in a normal heart rhythm (not atrial fibrillation or flutter) and be able to give your informed consent to take part.
Unfortunately, this study is not suitable for everyone. You wouldn't be able to take part if you need other types of heart surgery at the same time (like valve replacement), if your bypass surgery is an emergency, or if it's done without the heart-lung machine (off-pump CABG).
Other reasons you might not be able to join include having certain existing heart rhythm problems, already having a pacemaker or defibrillator, being pregnant, or if you've recently tested positive for Covid-19.
- Are you an adult aged 22 or over?
- Are you scheduled for heart bypass surgery (CABG)?
- Do you have heart failure with a weakened heart muscle (ejection fraction 20-40%)?
- Are you in a normal heart rhythm (not atrial fibrillation or flutter)?
- Are you able to give your consent to take part in a study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will be one of the first people to try this new pacing method. You will undergo a range of tests both before your bypass operation and during your recovery in the hospital. While you are recovering, you will have temporary wires connected to your heart, through which the new pacemaker rhythm will be delivered. You'll be monitored very closely by the medical team to check on your safety and how your heart is responding.
Researchers will compare the new heart pacing with the standard treatment to understand its effects. After you leave the hospital, there will be a follow-up phone call about one month after your surgery to check on your progress. The total duration of active study involvement using the temporary wires will be for up to 10 days while you are in hospital.
Potential risks and benefits
Locations (1)
- Cardiff & Vale University Health BoardCardiff, United Kingdom· Recruiting
Common questions
What is 'Respiratory Sinus Arrhythmia' (RSA)?
It's a natural heart rhythm where your heart speeds up slightly when you breathe in and slows down when you breathe out.
What is 'Heart Failure with Reduced Ejection Fraction' (HFrEF)?
This means your heart muscle is weakened and doesn't pump blood as effectively as it should.
Will I have a permanent pacemaker put in for this study?
No, this study uses temporary wires that are already put in during bypass surgery, and they will be removed before you leave the hospital.
What kind of tests will I have?
You'll have various heart tests before your operation and throughout your hospital stay to monitor your heart's function.
What if I change my mind about taking part?
You can withdraw from the study at any time without it affecting your medical care.
How to find out more
Susan Peirce, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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