Proof of Concept Study for 1 Lead Patch Technology

This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting.

Study Overview

• Status: Terminated
• Conditions: Telemetry
• Intervention / Treatment: Device: 1-Lead Patch

Detailed Description

This study is a two-phase evaluation of the use of a 1 Lead Patch System to monitor electrocardiogram (ECG) data and send the data to the LifeWatch Service Center, in the same manner as the existing ACT ambulatory telemetry system. It will be used in parallel with the standard 3 Lead ACT testing equipment used to monitor ECG outside the hospital. This study will not address safety or effectiveness and no comparator groups will be used. This study will not be treating any particular disease or condition and no randomization or blinding is required. Subjects will be selected in conjunction with their need for current outpatient telemetry monitoring.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mt. Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult male or female referred for 3 Lead ACT monitoring for between 7 and 14 days.
• Be recently prescribed a LifeWatch 3 Lead ACT monitor

Exclusion Criteria:

• under 21-years old
• pregnant or who may become become pregnant during the investigation period
• using internal or external defibrillators
• who are using pacemakers or implantable loop recorders
• showing skin damage on the chest, such as burns, irritation, infections, wounds, etc.
• meeting any contraindications for a patch biosensor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1-Lead Outpatient Telemetry; 1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.	Device: 1-Lead Patch; The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Outcome Measure - 100% Successful ECG Acquisition	Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.	Between 7 and 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch	Successful performance of the 1-Lead Patch adhesive throughout the study period for each subject. Subject skin irritation will be assessed upon initial placement of the 1-Lead Patch by the clinical caregiver. Subjects will be asked to self-assess skin irritation and to report to the clinician at the end of the trail period. Data were not collected.	Between 7 and 14 days

Collaborators and Investigators

• Sponsor: LifeWatch Services, Inc.
• Investigators: Principal Investigator: Vivek Reddy, MD FACC FHRS, Mt. Sinai Medical Center; Principal Investigator: Marie Noelle-Langan, MD, Mt. Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2014
• Primary Completion (Actual): June 9, 2016
• Study Completion (Actual): June 9, 2016

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CIP-F010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No