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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

1.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 guidelines14,
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)
2.Age 18 – 75 years,
3.Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Regular daily use of antiarrhythmic drugs of class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta-blockers permitted).
2.Previous AF ablation or surgery.
3.Severe heart failure (NYHA III-IV).
4.Reduced left ventricular ejection fraction (LVEF <30%).
5.Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml/m2) > 48.
6.Significant valvular disease requiring treatment or valve protesis.
7.Severe COPD stage III or chronic kidney disease (eGFR< 30 umol/l)).
8.Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months.
9.Myocardial infarction, revascularisation previous 6 months.
10.Stroke or TIA within previous 6 months.
11.Tachycardiomyopathy.
12.Dependent on VVI pacing.
13.Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs.
14.Expected survival less than 3 years, alcohol or drug abuse.
15.Participation in another trial or absence of consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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