Pappone 2006.
Methods | Randomised controlled trial. | |
Participants | Included patients with: Age >18 or<70 years; Creatinine concentration <1.5 mg/dl; AF history > 6 months; AF burden > 2 episodes/month in the last 6 months. 198 patients were included. 99 were arranged to CPVA group, and 99 to ADT group. Age: 55+/‐10 years in CPVA group, and 57+/‐10 years in ADT group. % of male: 69/99 (70%) in CPVA group, and 64/99 (65%) in ADT group. Follow‐up: 12 months. Location: Milan, Italy. |
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Interventions | Ablation group: Circumferential pulmonary vein ablation. ADT group: amiodarone, flecainide, or sotalol, either as single drugs or in combination, at the maximum tolerable doses. |
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Outcomes | Freedom from documented recurrent atrial tachycardia. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient detail was provided. |
Allocation concealment (selection bias) | Unclear risk | B‐Unclear. The authors did not depict allocation concealment method. |
Blinding | High risk | Blinding was not reported. |
Incomplete outcome data addressed | High risk | There were no patients withdrawn or lost to follow up. |
Adequate sequence generation | Unclear risk | It was not addressed. |