MANTRA-PAF TRIAL

Problem Paroxysmal AF (first line)

Format Multicenter, randomised trial

Treatment Radiofrequency catheter ablation

Control Class IC or class III antiarrhythmic agents

Population 294 patients

Inclusion criteria At least two episodes of symptomatic atrial fibrillation within the preceding 6 months but no episode of atrial fibrillation that was longer than 7 days (without spontaneous termination or cardioversion)

Exclusion criteria Age of more than 70 years

Previous or ongoing treatment with class IC or class III antiarrhythmic drugs

Contraindication to both class IC and class III agents

Previous ablation for atrial fibrillation

Left atrial diameter of more than 50 mm

Left ventricular ejection fraction of less than 40%

Contraindication to oral anticoagulation therapy

Moderate-to-severe mitral valve disease

Severe heart failure (New York Heart Association functional class III to IV at the time of enrollment)

Expected surgery for structural heart disease

Secondary atrial fibrillation (due to cardiac surgery, infection, or hyperthyroidism).

Follow-up 24 months

Primary endpoint Percentage of time in atrial fibrillation on 7 Holter-monitor recordings at 3, 6, 12, 18, and 24 months

(Only episodes of atrial fibrillation longer than 1 minute were included in the analysis)

Secondary endpoint(s) Freedom from any atrial fibrillation and freedom from symptomatic atrial fibrillation at 24 months of follow-up

Cumulative and per-visit burden of symptomatic atrial fibrillation

Time to first recurrence of atrial fibrillation after the blanking period

Atrial flutter longer than 1 minute

Quality of life was assessed at baseline and at 12 and 24 months with the use of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical-component summary score and mental-component summary score (both of which range from 0 to 100, with higher scores indicating greater well-being)

Details .