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Proof of Concept Study for 1 Lead Patch Technology

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ClinicalTrials.gov Identifier: NCT02533531
Recruitment Status : Terminated (Study was halted to make device updates)
First Posted : August 26, 2015
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
LifeWatch Services, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Telemetry Device: 1-Lead Patch Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Proof of Concept Study for 1 Lead Patch Technology
Actual Study Start Date : April 16, 2014
Actual Primary Completion Date : June 9, 2016
Actual Study Completion Date : June 9, 2016
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Composite Outcome Measure - 100% Successful ECG Acquisition [ Time Frame: Between 7 and 14 days ]
    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.


Secondary Outcome Measures :
  1. Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch [ Time Frame: Between 7 and 14 days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533531


Locations
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United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
LifeWatch Services, Inc.
Investigators
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Principal Investigator: Vivek Reddy, MD FACC FHRS Mt. Sinai Medical Center
Principal Investigator: Marie Noelle-Langan, MD Mt. Sinai Medical Center
More Information
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Responsible Party: LifeWatch Services, Inc.
ClinicalTrials.gov Identifier: NCT02533531    
Other Study ID Numbers: CIP-F010
First Posted: August 26, 2015    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: March 2018

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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