Rationale and design of the Lead Evaluation for Defibrillation and Reliability study: Safety and efficacy of a novel ICD lead design.

George H Crossley,Prashanthan Sanders,Paolo De Filippo,Khaldoun G Tarakji,Bert Hansky,Maully Shah,Pamela Mason,Baerbel Maus,Keith Holloman

Journal of cardiovascular electrophysiology（2023）

引用 4|浏览8

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摘要

The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.

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关键词

adaptive design,defibrillation lead,virtual patient modeling

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