Status:
COMPLETED
The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System
Lead Sponsor:
LIVMOR, Inc.
Collaborating Sponsors:
Texas Health Dallas
North Texas Veterans Healthcare System
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 visibilit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2019
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT04104191
Start Date
July 27 2017
End Date
February 14 2019
Last Update
September 26 2019
Active Locations (2)
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1
VA North Texas Health Care System
Dallas, Texas, United States, 75216
2
Texas Health Dallas
Dallas, Texas, United States, 75231