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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104191
• Other study ID #: CIP-1001
• Status: Completed
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: February 14, 2019

Study information

• Verified date: September 2019
• Source: LIVMOR, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: February 14, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	Texas Health Dallas	Dallas	Texas
United States	VA North Texas Health Care System	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
LIVMOR, Inc.	North Texas Veterans Healthcare System, Texas Health Dallas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concurrent Atrial Fibrillation	Simultaneous ECG monitoring indicating Atrial Fibrillation rhythm.	10 minutes
Primary	Detection of Atrial Fibrillation	A decision of Atrial Fibrillation detection in at least one 192-beat window.	10 minutes