Atrial Fibrillation Clinical Trial
Official title:
The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System
The LIVMOR Data Collection Study is a multicenter, IDE Exempt Study to generate a library of device-specific signals collected noninvasively. The study was not designed to evaluate specific hypothesis or endpoint, rather it was intended for data collection purposes to generate a library of raw clinical data that were retrospectively used for the development and subsequently the validation of the L-1000AF System. The L-1000AF System is a wrist worn system intended to provide continuous remote monitoring of atrial fibrillation (AF) episodes. The system is intended for use under the care of a physician and is not intended for the diagnosis of AF.
LIVMOR is developing a series of wearable medical device systems intended to promote general
wellness and help subjects and physicians manage various diseases that can benefit from
increased visibility of physical activity, sleep, weight, blood pressure, stress/recovery
levels and cardiac rhythms.
Data from human subjects is necessary to develop and validate LIVMOR devices. LIVMOR
completed a multicenter, IDE Exempt Study to generate a library of device-specific signals
collected non-invasively using components of the LIVMOR system and simultaneously acquired
with ECG Holter data using a commercially available Holter monitor. Data from the analysis of
the Holter monitor was adjudicated by physicians skilled in the analysis and interpretation
of ECGs compared to the analysis from the LIVMOR AF Detection Algorithm to establish the
sensitivity and specificity of the algorithm for detection of AF in comparison to ground
truth.
The study was not designed to evaluate specific hypotheses or endpoint, rather it was
intended for data collection purposes to generate a library of raw clinical data that were
retrospectively used for the development and subsequently the validation of the L-1000AF
System.
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