Trials of implantable monitoring devices in heart failure: which design is optimal?

摘要: Implantable monitoring devices have been developed to detect early evidence of heart failure (HF) decompensation, with the hypothesis that detection might enable clinicians commence therapy sooner than would otherwise be possible, and potentially reduce rate hospitalization. In addition usual challenges inherent device trials (such as difficulty double-blinding potential for bias), studies implantable present unique difficulties because they involve assessment therapeutic end points diagnostic devices. Problems include lack uniform approaches treatment in study protocols alerts or out-of-range values, requirement levels traditionally associated establish effectiveness safety. this Review, used deal these issues are discussed, including use objective primary blinded adjudication, identical duration follow-up number encounters patients active control groups, recommendations between groups consistent international guidelines. Remote hold promise reducing hospitalization among HF. However, optimization regulatory clinical trial design is needed facilitate further evaluation combining health information technology medical