Clinical trial NCT04104191: The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System
Official title: The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: LIVMOR, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Texas Health Dallas
name: North Texas Veterans Healthcare System
First posted: 2019-09-26
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Concurrent Atrial Fibrillation
timeFrame: 10 minutes
measure: Detection of Atrial Fibrillation
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Dallas
country: United States
facility: Texas Health Dallas
state: Texas
Study officials:
affiliation: Texas Health Dallas
name: Tony Das, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Texas Veterans Healthcare System
name: Subhash Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LIVMOR, Inc.
name: Ken Persen
role: STUDY_DIRECTOR
References: