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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: L-1000AF System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System
    • Dallas, Texas, United States, 75231
      • Texas Health Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LIVMOR, Inc.
• Collaborators: North Texas Veterans Healthcare System; Texas Health Dallas
• Investigators: Principal Investigator: Tony Das, MD, Texas Health Dallas; Study Director: Ken Persen, LIVMOR, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2017
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CIP-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No