NCT02533531

Proof of Concept Study for 1 Lead Patch Technology

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: LifeWatch Services, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Telemetry

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-04-16
• Primary completion: 2016-06-09
• Completion: 2016-06-09
• First posted: 2015-08-26
• Last updated: 2018-04-06
• Results posted: 2018-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study