Proof of Concept Study for 1 Lead Patch Technology

LifeWatch Services

Status: Terminated

Conditions: Telemetry

Treatments: Device: 1-Lead Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT02533531

CIP-F010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

1-Lead Outpatient Telemetry

Experimental group

Description:

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.

Treatment:

Device: 1-Lead Patch