Proof of Concept Study for 1 Lead Patch Technology

Telemetry Clinical Trial

Official title:

Proof of Concept Study for 1 Lead Patch Technology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02533531
• Other study ID #: CIP-F010
• Status: Terminated
• Phase: N/A
• First received: August 25, 2015
• Last updated: April 4, 2018
• Start date: April 16, 2014
• Est. completion date: June 9, 2016

Study information

• Verified date: March 2018
• Source: LifeWatch Services, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 9, 2016
• Est. primary completion date: June 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Telemetry

Intervention

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.

Locations

Country	Name	City	State
United States	Mt. Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
LifeWatch Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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