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Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data.

PMID: 39720009 · 2024-12-19

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ЖурналPragmatic and observational research

Год2024-12-19

PMID39720009

Аннотация

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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