ICD Registry DELTA Active Surveillance Pilot Study

  • Overview

    The Data Extraction and Longitudinal Trend Analysis (DELTA) surveillance system was developed to monitor ongoing clinical datasets to detect emerging differences in safety or efficacy of medical devices. This project is an observational study that assesses the validity of DELTA surveillance in monitoring high-energy implantable cardiac defibrillator (ICD) leads and utilizes the propensity-matched survival method applied dynamically to the National Cardiovascular Data Registry (NCDR) ICD Registry.

  • Impact for NESTcc

    This project would validate time-dependent adverse event surveillance projects with possible alternatives to post-approval studies.

  • Organizations

    American College of Cardiology (ACC), Center for Devices and Radiological Health (CDRH), Lahey Hospital and Medical Center (Tufts University School of Medicine), NCDR ICD Registry

  • Principal Investigators

    Frederic S. Resnic, MD, Lahey Hospital and Medical Center

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NESTcc's Test-Case study protocol on synthetic mid-urethral slings for stress urinary incontinence in women is open for public comment through June 12. More: bit.ly/2RM654T pic.twitter.com/fk4ore1Kmg 1 day ago

NESTcc is requesting public comments on the study protocol of our Test-Case focused on synthetic mid-urethral slings for stress urinary incontinence in women. The comment period is open until June 12. More: bit.ly/2RM654T pic.twitter.com/5owFLFq1Fl 1 week ago

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