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Activity Number: 247 - Wearable/Implantable Device Data in Clinical Trials
Type: Invited
Date/Time: Tuesday, August 4, 2020 : 1:00 PM to 2:50 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #309444
Title: Use of Accelerometer Data to Evaluate Physical Activity as a Surrogate Endpoint in Heart Failure Clinical Trials
Author(s): Tracy Bergemann*
Companies: Medtronic
Keywords: Mobile technologies; Clinical trials; Physical activity; Surrogate endpoints

Physical activity levels in heart failure patients have shown a correlation with neurocognition and traditional functional assessments, such as the exercise capacity test. Accelerometers from implantable cardiac devices provide the opportunity to collect objective data as a heart failure patient goes about their daily activities. While increases in physical activity have face validity as a study objective, changes in summaries of the accelerometer recordings may also function as a surrogate endpoint for traditional heart failure clinical outcomes. Patient level accelerometer, baseline, and clinical outcomes data from seven different randomized clinical trials of cardiac implantable devices were compiled. All trials had statistically significant primary outcomes. Summaries of accelerometer data over time are assessed as potential surrogate endpoints for future trials. Methods of assessment are described. The challenges inherit in the data analyzed, for e.g., missing data, variability, timing of collection, and their impact will be discussed. Several hypotheses are suggested that may improve the prospect of accelerometer data being used for surrogate endpoints in the future.

Authors who are presenting talks have a * after their name.

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