Oral 2006.
Methods | Randomised controlled trial. | |
Participants | Patients with chronic atrial fibrillation. A total of 146 patients were randomised. 77 assigned to CPVA, while 69 assigned to control group. Age: 58+/‐8 years in control group, and 55+/‐9 years in CPVA group. % of male: 62/69 (90%) in control group, and 67/77 (87%) in CPVA group. Follow‐up: 12 months. Location: Ann Arbor, Michigan. |
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Interventions | Circumferential pulmonary vein ablation. Control group: 200mg of amiodarone orally per day at least six weeks after randomisation before transthoracic cardioversion. |
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Outcomes | Freedom from AF and atrial flutter in 1 year. Incidence of complications, changes in the diameter of the left atrium and the LVEF, changes in the severity of symptoms. | |
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Incomplete outcome data addressed | High risk | There were no patients withdrawn or lost to follow up.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. |