Expired Study
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New York, New York 10029


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02533531


Primary Contact:

Principal Investigator
Vivek Reddy, MD FACC FHRS
Mt. Sinai Medical Center


Backup Contact:

N/A


Location Contact:

New York, New York 10029
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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