Proof of Concept Study for 1 Lead Patch Technology

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-16

Study Completion Date

2016-06-09

Brief Summary

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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.

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Detailed Description

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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

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Telemetry

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

1-Lead Patch

Intervention Type DEVICE

The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes