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

NCT04104191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2019-09-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

L-1000AF System

The L-1000AF System is a wrist worn system that analyzes pulse rate data. The system identifies atrial fibrillation rhythms.

Sponsors & Collaborators

  • Texas Health Dallas

    collaborator UNKNOWN

  • North Texas Veterans Healthcare System

    collaborator FED

  • LIVMOR, Inc.

    lead INDUSTRY

Principal Investigators

  • Tony Das, MD · Texas Health Dallas

  • Subhash Banerjee, MD · North Texas Veterans Healthcare System

  • Ken Persen · LIVMOR, Inc.

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-27
Primary Completion
2019-02-13
Completion
2019-02-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104191 on ClinicalTrials.gov