- Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT06505798.
- What is being tested: This trial compares three catheter ablation techniques (cryoballoon, radiofrequency, and pulsed field ablation) against standard medical management (rate control and anti-arrhythmic drugs) for treating atrial fibrillation, particularly in patients with heart failure.
- Patient eligibility overview: The trial includes patients with atrial fibrillation who have concurrent heart failure or are at risk of developing it; participants must be suitable candidates for ablation procedures and willing to be randomised to either intervention or medical therapy.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
Atrial fibrillation (AF) is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure (HF). Treatments include drugs to slow the heart rate, anti-arrhythmic drugs or ablation of the heart to help preserve normal rhythm. A number of trials have suggested that ablation may be superior to drug treatment to reduce hospitalisations or prevent early death. However, these studies have been small and the results not applicable to the general population with AF and heart failure in the UK. This international study…
- : 1. Patients aged ≥18 years.
- Patient is willing and able to give informed consent for participation. 3. Able and willing to comply with all study requirements, including ability to participate in study for 12 months. 4. Willing to allow their General Practitioner (GP) to be notified of participation in the study.
- Patient with one of the following AF categories and at least one episode of AF documented (by any means eg ECG, Holter, Cardiac Implantable Electronic Device (CIED) interrogation or any other means): * Paroxysmal AF defined as spontaneous self-terminating AF lasted > 6 hours and 7 days but not >3 years (since 1st documentation) 6. Optimal tolerated medical therapy for HF (including ACE-I (or ARB or ARNi), beta-blocker, SGLT2 inhibitor and mineralocorticoid receptor antagonist (MRA) and cardiac resynchronisation therapy (CRT) where indicated & tolerated) for at least 6 weeks (according to the most contemporary European Society of Cardiology (ESC) HF guidelines). Maximal doses of these drugs are not mandated. 7. New York Heart Association Classification (NYHA) class II to III 8. LVEF
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.