PubMed

使用真实世界数据的首次心脏导线上市后批准研究验证和最终结果。

PMID：39720009 · 2024-12-19

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期刊Pragmatic and observational research

年份2024-12-19

PMID39720009

摘要

As part of Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION), a multi-stakeholder collaboration between the US Food and Drug Administration (FDA), academic and society partners, and cardiovascular implantable electronic device manufacturers, a 5-year bradycardia lead study transitioned from a traditional post-approval study (PAS) to a real-world data (RWD) approach using a novel method to evaluate chronic cardiac lead complications. Lead complicatio

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