Status:
ACTIVE_NOT_RECRUITING
Ablation of Fibrotic Areas in Patients With Persistent Atrial Fibrillation.
Lead Sponsor:
Karolinska University Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wi...
Detailed Description
Background: Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence of 2-3 percent in the population. Catheter ablation performing pulmonary vein isolation (PVI)...
Eligibility Criteria
Inclusion
- ECG-documented persistent or long-standing persistent atrial fibrillation according to European Society of Cardiology (ESC) definition
- Symptoms e. g. palpitations, dyspnea, tiredness that is due to the atrial fibrillation.
- Suitable candidate for catheter ablation.
- Tried one or more antiarrhythmic drugs or unwilling to try antiarrhythmic drugs
- Age ≥18 years.
Exclusion
- LA dimension \>55 mm as determined by an echocardiography within the previous year
- Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
- Severe aortic or mitral valvular heart disease using the ESC guidelines
- Congenital heart disease
- Prior surgical or percutaneous AF ablation procedure or atrioventricular-nodal ablation
- Medical condition likely to limit survival to \< 1 year
- New York Heart Association (NYHA) class IV heart failure symptoms
- Contraindication to oral anticoagulation
- Renal failure requiring dialysis
- AF due to reversible cause
- Pregnant and fertile women without anticonception
- History of non-compliance to medical therapy
- Unable or unwilling to provide informed consent
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 11 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04377594
Start Date
May 20 2020
End Date
April 11 2026
Last Update
December 10 2025
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Stockholm County, Sweden, SE-14186