Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
This research is investigating a procedure called catheter ablation for people with severe heart failure who also have dangerous irregular heartbeats. The study wants to find out if performing this procedure early on, before these irregular rhythms cause major issues, can make a difference. Researchers will compare this approach to standard medical treatment. They are hoping to see if early ablation can help prevent deaths, reduce the need for urgent heart transplants, or lower the chance of needing a special heart pump (LVAD). It also looks at how this treatment might affect hospital stays, quality of life, and other heart-related problems. The study will involve 160 patients and follow them for two years.
At a glance
What is this study about?
When your heart doesn't pump blood around your body as well as it should, it's called heart failure. In severe cases, this can lead to life-threatening irregular heartbeats (ventricular arrhythmias). Sometimes, these irregular beats are caused by damaged areas, or 'scars,' in the heart muscle, often from previous heart attacks.
This study is looking at a treatment called catheter ablation. This procedure involves carefully guiding thin tubes (catheters) into the heart to find and fix the specific areas causing the irregular heartbeats. The doctors will try to gently treat these scarred areas while the heart is beating normally. The main goal is to see if doing this procedure proactively (before a serious emergency) can improve the lives of people with severe heart failure. They want to know if it can prevent early death, reduce the need for urgent heart transplants, or avoid the need for a special device to help the heart pump.
Researchers will also be monitoring other important things, like how many times people need to go to the hospital, their overall quality of life, how well their heart works, and how much exercise they can do. By comparing patients who have the ablation procedure with those who receive standard medical care, the study hopes to understand if this early treatment is a helpful option for people with severe heart failure and irregular heartbeats.
Key takeaways
- This study evaluates an early procedure for severe heart failure and irregular heartbeats.
- It aims to reduce serious problems like needing an urgent heart transplant.
- Patients are followed for two years to monitor their health.
- It helps doctors understand if this treatment improves lives for people with advanced heart failure.
- Participation involves either the procedure plus usual care, or usual care alone.
Who may be eligible?
To join this study, generally, you would need to be an adult (18 years or older) with severe heart failure caused by a previous heart attack. Your heart's pumping ability would be significantly weakened, and you'd be experiencing severe symptoms in your daily life, making it hard to exercise. You would also need to be considered for a heart transplant.
There are also some reasons why you might not be able to join. For example, if you've already had a catheter ablation for irregular heartbeats, or if you've recently had a serious heart event like a heart attack, stroke, or heart surgery. Certain other health conditions, like uncontrolled high blood pressure or needing dialysis, would also prevent you from taking part. You also couldn't participate if you're pregnant or breastfeeding, or if you're very unwell with a life expectancy of less than a year.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have severe heart failure caused by a previous heart attack?
- Are you short of breath or tired even with light activity?
- Are you being considered for a heart transplant?
- Have you NOT had a catheter ablation for irregular heartbeats before?
- Have you NOT had a heart attack, stroke, or heart surgery in the last month?
What does participation involve?
If you join this study, you would either receive the catheter ablation procedure alongside your usual medical care, or continue with your usual medical care alone. The ablation procedure involves being in the hospital for a short time. You would have regular check-ups and tests over a two-year period to monitor your heart health, how you feel, and any changes in your symptoms. The study will also track things like hospital visits and any treatments you receive for irregular heartbeats. You would need to be willing to follow the study plan and attend all scheduled appointments for the full two years.
Potential risks and benefits
Locations (1)
- Clinic for Electrophysiology, Herz- und Diabeteszentrum NRWVerified postcodeBad Oeynhausen, Germany· Recruiting
Common questions
What is catheter ablation?
It's a procedure using thin tubes (catheters) guided into your heart to treat areas causing irregular heartbeats.
What is 'advanced heart failure'?
This means your heart is very weak, causing severe symptoms that affect your daily life, and you might be considered for a heart transplant.
Will I get the ablation procedure if I join?
Patients will be put into groups by chance. One group will have the ablation, and the other will continue with standard medical care.
How long will the study last for me?
If you join, you will be followed closely for a period of two years.
What is an 'ICD'?
An ICD is a small device implanted in your chest that can deliver an electric shock to correct dangerous irregular heart rhythms.
How to find out more
Christian Sohns, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.