The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System
Completed · Not applicable
Conditions studied: Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT04104191
- Run by
- LIVMOR, Inc.
- People needed
- 271
- Starts
- 2017-07-27
- Expected to finish
- 2019-02-14
- Last updated by the study team
- 2019-09-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- VA North Texas Health Care System — Dallas, Texas, United States
- Texas Health Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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