Radio frequency ablation: Two different radio frequency ablation procedures
Study summary
Brief summary: The objective of this study is to compare two different ablation strategies in participants with persistent atrial fibrillation and fibrotic areas in the left atrium. The participant will be randomized to pulmonary vein isolation or pulmonary vein isolation plus ablation of fibrotic areas.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. ECG-documented persistent or long-standing persistent atrial fibrillation according to European Society of Cardiology (ESC) definition
2. Symptoms e. g. palpitations, dyspnea, tiredness that is due to the atrial fibrillation.
3. Suitable candidate for catheter ablation.
4. Tried one or more antiarrhythmic drugs or unwilling to try antiarrhythmic drugs
5. Age ≥18 years.
Exclusion Criteria:
1. LA dimension \>55 mm as determined by an echocardiography within the previous year
2. Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
3. Severe aortic or mitral valvular heart disease using the ESC guidelines
4. Congenital heart disease
5. Prior surgical or percutaneous AF ablation procedure or atrioventricular-nodal ablation
6. Medical condition likely to limit survival to \< 1 year
7. New York Heart Association (NYHA) class IV heart failure symptoms
8. Contraindication to oral anticoagulation
9. Renal failure requiring dialysis
10. AF due to reversible cause
11. Pregnant and fertile women without anticonception
12. History of non-compliance to medical therapy
13. Unable or unwilling to provide informed consent
Primary outcome measure(s)
Number of Participants with Freedom from Atrial Arrhythmia — From 3 months (blanking period) to 12 months after the first ablation procedure Freedom from documented atrial arrhythmias \>30 seconds at 12 months after 1 or 2 ablation procedures within 6 months without antiarrhythmic drugs
Trial sites (1)
Facility
City
Region
Status
Karolinska University Hospital
Stockholm
Stockholm County
More Karolinska University Hospital trials in Sweden
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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