16 research outputs found

    Cumulative shock energy.

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    <p>Cumulative shock energy applied on the myocardium during safety margin testing or upper limit of vulnerability testing according to randomization and adjusted to the different energy levels applicable to the devices of different manufacturers.</p><p>Cumulative shock energy.</p

    Secondary endpoint; increase in CK [U/l] (intention-to-treat) for all randomization groups.

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    <p>CK = Creatinkinase, No Shock = Implantation without ICD testing, ULV = Upper Limit of Vulnerability Testing, VF = Induction of Ventricular Fibrillation (traditional safety margin testing).</p

    Effect of short-term AADs use versus no-AADs prescription after AF ablation on early recurrence of atrial arrhythmias.

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    <p>AADs = antiarrhythmic drugs; CI = confidence intervals. TSA results showed that the cumulative Z-curve crossed both the conventional boundary for benefit and the trial sequential monitoring boundary for benefit and entered the area of benefit, which established sufficient and conclusive evidence. X-axis: the number of patients included; Y-axis: the cumulative Z-Score; The red dotted lines: conventional boundaries (Z-score = 1.96, two-sided P value = 0.05); The red etched lines: trial sequential monitoring boundaries; Blue full line: the cumulative Z-curve; Vertical red etched line: the estimated required information size; The estimated required information size of 4538 patients was calculated using α = 0.05 (two sided), β = 0.20 (power 80%), an anticipated relative risk reduction of 25%, and an event proportion of 46.9% in the control group. Upper green square area: area of benefit; Middle faint yellow square area: futility area; Lower red square area: area of harm.</p
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