The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: L-1000AF System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing, able and sufficiently motivated to attend all study visits and participate in all study activities; and Physically and mentally capable of providing informed consent and are at least 18 years of age or of legal age to provide consent as required by local and national requirements. Exclusion Criteria: Has any unstable or significant medical condition that is likely to interfere with study procedures or subjects medical care; Has any implantable electronic medical device; Has significant hearing, visual or cognitive impairment as determined by the Investigator; and Participating in any other clinical study without written consent from the Sponsor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-1000AF System<br>Software device on a wearable device used to detect irregular heart rhythms suggestive of Atrial Fibrillation | Device: L-1000AF System<br>* The L-1000AF System is a wrist worn system that analyzes pulse rate data. The system identifies atrial fibrillation rhythms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concurrent Atrial Fibrillation | Simultaneous ECG monitoring indicating Atrial Fibrillation rhythm. | 10 minutes | 
| Detection of Atrial Fibrillation | A decision of Atrial Fibrillation detection in at least one 192-beat window. | 10 minutes |