Willems 2006.
Methods | Randomised by random number table | |
Participants | Included patients with:1) at least 2 failed attempts of an antiarrhythmic drug therapy for symptomatic AF episodes; 2) persistent AF lasting for at least 1 month documented by daily trans‐telephonic transmitted ECG. 62 patients were enrolled. 32 were arranged to PVI plus SM group, and 30 to PVI alone group. Age: 58.3+/‐11.8 years in PVI+SM group, and 60.1+/‐9.3 years in PVI alone group. % of male: unknown. Follow‐up:487 days (range from 429 to 570 days). Location: Hamburg, Germany. |
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Interventions | Pulmonary vein isolation plus additional substrate modification compared to PVI alone. | |
Outcomes | Complications | |
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Incomplete outcome data addressed | High risk | There were no patients withdrawn or lost to follow up.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 | Low risk | Sequence was generated by randomised number table. |