PASSReviewer 1· 90% conf
The trial design is rigorous with adequate randomization, blinding (open-label with rationale), power analysis, and inclusion/exclusion criteria.
Evidence
direct quote[Methods, Trial design]
“Randomization allocation was computer generated through a central concealed process and each site was informed online. A minimization method using participating hospitals as an adjustment factor was used so as not to cause large deviation within each hospital.”direct quote[Methods, Statistical analysis]
“With a randomization ratio of 1:1, a sample size of 155 participants in each group was required to reject the null hypothesis with a power of 80% and a significance level of 5%.”direct quote[Methods, Trial participants]
“Exclusion criteria were age <20 years, left atrial diameter ≥55 mm, history of cardiac surgery, valvular AF, hemodialysis, contraindication to ablation, contraindication to anticoagulant therapy, history of stroke or systemic embolism within the last 6 months, treatable cause of AF, pregnancy and physician’s judgment of unsuitability for enrollment.”PASSReviewer 2· 95% conf
The trial design is rigorous with adequate randomization, blinding (open-label with rationale), power analysis, and inclusion/exclusion criteria.
Evidence
direct quote[Methods, Trial participants]
“Randomization allocation was computer generated through a central concealed process and each site was informed online.”direct quote[Methods, Trial design]
“A prospective, investigator-initiated, multicenter, randomized, open-label SUPPRESS-AF trial was conducted at eight centers in Japan.”direct quote[Methods, Statistical analysis]
“With a randomization ratio of 1:1, a sample size of 155 participants in each group was required to reject the null hypothesis with a power of 80% and a significance level of 5%.”