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

NCT04104191 | Completed FDA Device

• 1 other identifier: CIP-1001
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Concurrent Atrial Fibrillation

  Simultaneous ECG monitoring indicating Atrial Fibrillation rhythm.

  10 minutes

• Detection of Atrial Fibrillation

  A decision of Atrial Fibrillation detection in at least one 192-beat window.

  10 minutes

Study Arms (1)

L-1000AF System

EXPERIMENTAL

Software device on a wearable device used to detect irregular heart rhythms suggestive of Atrial Fibrillation

Device: L-1000AF System

Interventions

L-1000AF System DEVICE

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

L-1000AF System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• LIVMOR, Inc.: lead
• Texas Health Dallas: collaborator
• North Texas Veterans Healthcare System: collaborator

Study Sites (2)

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Texas Health Dallas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tony Das, MD

  Texas Health Dallas

  PRINCIPAL INVESTIGATOR

• Subhash Banerjee, MD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

• Ken Persen

  LIVMOR, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: July 27, 2017
• Primary Completion: February 13, 2019
• Study Completion: February 14, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

US (2)