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.
Organization(s): 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 Investigator(s): Frederic S. Resnic, MD (Lahey Hospital and Medical Center)