Methods |
RCT comparing high‐rate and delayed therapy versus conventional therapy (implantable cardioverter‐defibrillator) in arrhythmias (ischaemic or non ischaemic heart disease). |
Data |
1500 patients were randomised (986/514, respectively in each treatment group). |
Comparisons |
Onsite assessment (unblinded local investigator) versus assessment by a device‐interrogation committee (blinding status not reported) reviewing suspected events by algorithm of implanted devices (i.e., all device interrogations with use of electronic media downloaded from device interrogations at the enrolling centres). |
Outcomes |
The outcome selected was the first occurrence of inappropriate therapy.This was the study's prespecified primary outcome. |
Notes |
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Risk of bias |
Item |
Authors' judgement |
Description |
Method for selecting cases to adjudicate? |
No |
Events identified as suspected by an algorithm of the implanted devices were reviewed independently to the onsite assessor. |