First-line catheter ablation for early treatment of Persistent (ongoing unless cardioverted) Atrial Fibrillation (AF) – a randomized study comparing isolation of pulmonary veins triggering AF using a Cryoballoon versus antiarrhythmic medication.

Prior treatment

• Regular daily use of antiarrhythmic drugs of class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta- blockers permitted).
• Myocardial infarction, revascularisation previous 6 months.
• Stroke or TIA within previous 6 months.
• Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs.
• Expected survival less than 3 years, alcohol or drug abuse.
• Previous AF ablation or surgery.

Other illness

• Severe heart failure (NYHA III-IV).
• Significant valvular disease requiring treatment or valve protesis.
• Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months.

Lab values

• Reduced left ventricular ejection fraction (LVEF ≤40 % during sinus rhythm).
• Severe COPD stage III or chronic kidney disease (eGFR< 30 umol/l).

Other

• Tachycardiomyopathy.
• Dependent on VVI pacing.
• Participation in another trial or absence of consent.
• Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
• Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml/m2) > 48.

• Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months (both shorter than 12 months in duration), the latest episode within the previous 6 months and, one should be documented on a 12 lead ECG or Holter monitor. a) Classical persistent AF as defined by ESC guidelines, b) Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion of episodes to sinus rhythm is lacking in near time)
• Age 18 – 75 years
• Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF. As an example, BMI >35 would not according to clinical praxis be a candidate for AF ablation and thereby not suitable for participation in the study.