AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation

To be able to join this study, you need to be at least 18 years old. You must have been diagnosed with atrial fibrillation that your doctors don't believe can be controlled by other treatments. You also need to have stable heart failure and have been hospitalised or visited an emergency room due to your heart failure in the past two years, even though you've been taking your prescribed medications. Finally, you must understand the study and be willing to give your permission to take part.

There are also some reasons why you wouldn't be able to join. For example, if your heart failure is very severe (known as NYHA functional class IV), or if you have another serious illness that isn't related to your heart. You also can't participate if you've already had a pacemaker implanted and it's heavily used, or if you need heart surgery. Additionally, if you've had certain serious medical events like a heart attack, stroke, or major bleeding in the last three months, or heart bypass surgery in the last six months, you cannot join. Women who are pregnant or breastfeeding are also not able to take part.

If you decide to take part, you will have the AV node ablation procedure. After this, you will be randomly chosen to receive either the conduction system pacing device or the cardiac resynchronization therapy (CRT) device – like flipping a coin, neither you nor your doctor can choose. You will then have several follow-up appointments, some in person at the clinic and some by phone. These will be at the start of the study, on the day of your procedure, then at 3 months, 12 months, 24 months, and 36 months afterwards.

Throughout the study, you'll be asked to fill out questionnaires about your heart failure symptoms and how your quality of life is. You'll do this at the beginning, at 12 months, and then once a year. You'll also have an echocardiogram (an ultrasound scan of your heart), an electrocardiogram (ECG, which checks your heart's electrical activity), and blood tests at the start and after one year. Some participants at certain hospitals will also be asked to wear a bracelet that measures how stiff your arteries are for 30 minutes and provide a urine sample, both at the start and after one year.