Cryoballoon/Radiofrequency Ablation of Atrial Fibrillation Versus Medical Treatment for Heart

Launched by UNIVERSITY COLLEGE, LONDON · Jul 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a procedure called catheter ablation compared to standard drug treatment for patients with atrial fibrillation (AF), a common heart rhythm disorder that can lead to heart failure. The goal is to see if the ablation procedure can help reduce hospital visits for heart failure, lower the risk of death, and improve patients' quality of life. The trial will involve participants who are between 18 and 74 years old and have certain types of AF, along with moderate to severe heart failure symptoms.

To join the trial, participants need to have documented atrial fibrillation, be receiving optimal medical therapy for heart failure, and meet specific heart function criteria. Participants can expect to be involved for about 12 months, during which they will be closely monitored to assess the effects of treatment. It’s important to note that individuals with certain medical conditions or recent heart events may not be eligible. This study aims to provide better insights into the best treatment options for people with AF and heart failure.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged ≥18 years.
• • 2. 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.
• 5. Patient with one of the following AF categories and at least one electrocardiogram (ECG) documentation of AF:
• • Paroxysmal AF defined as spontaneous self-terminating AF lasted \> 6 hours and \<7 days.
• • Persistent AF as defined by at least one episode of AF \>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 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 \<50% (Cardiac imaging report of LVEF\<50% within 1 year (by echocardiography, cardiac magnetic resonance imaging or nuclear cardiology assessment)) AND after optimisation of medical therapy (see previous definition).
• • 1. For those with LVEF 41-49% and without ongoing atrial fibrillation/flutter, N-terminal-pro B-type natriuretic peptide (NTproBNP) of ≥300pg/mL is required.
• • 2. For those with LVEF 41-49% and with ongoing atrial fibrillation/flutter, NTproBNP of ≥600pg/mL is required.
• • 3. For those with LVEF ≤40%, NTproBNP is not required.
• Exclusion Criteria:
• • 1. Long standing (\>3 year) persistent or permanent AF.
• • 2. Previous atrioventricular (AV) nodal ablation
• • 3. Previous pulmonary vein isolation (PVI) or surgical ablation.
• • 4. Recent (\<90 days) (type 1 spontaneous) myocardial infarction (type 2 myocardial infarctions are not an exclusion criterion), percutaneous coronary intervention, coronary artery bypass grafting, cardiac resynchronisation therapy or stroke.
• • 5. Severe aortic or pulmonary valve disease.
• • 6. Severe primary or secondary mitral valve regurgitation.
• • 7. Active illness (other than HF) likely to result in death within 2 years.
• • 8. Women who are pregnant or planning to become pregnant during the trial (Females of childbearing potential must have a negative pregnancy test seven days or fewer prior to enrolment).
• • 9. Females who are breastfeeding.
• • 10. Known allergy to contrast.
• • 11. Contraindication for PVI.
• • 12. Other conditions that may prevent subjects from adhering to the trial protocol, in the opinion of the investigator.
• • 13. Currently participating in another randomised controlled trial of another drug or medical device.