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Clinical Studies

Closed for Enrollment

  • Collection of Single-Lead ECG Data Using Prototype MoMe ARC 1-Lead Patch for Analysis Using Current Multi-lead ECG Algorithms Rochester, MN

    The primary objective of this study is to collect data from a single-lead ECG patch device (MoMe ARC 1-Lead Patch) for evaluation using InfoBionic ECG automated algorithms (FDA 510(k) = K152491) to make any needed adjustments for use in single-lead ECG data that will be included in FDA 510(k) submission for MoMe ARC Modular System. Data collection will be completed in both outpatient and inpatient subjects undergoing clinically indicated cardiac rhythm monitoring for previously diagnosed cardiac rhythm abnormatlities or exploratory monitoring for evaluation of symptoms and risk factors.
  • Smart Clothing for the Detection of Cardiac Electrical Activity and Arrhythmias Rochester, MN

    The purpose of this study is to examine the fidelity of the electrical signal produced from non-adhesive textile electrodes in a chestband based form factor, to compare signals obtained between the chestband based form factor and the clinical 12 lead ECG recording done on the same day, and to assess the performance of an atrial fibrillation detection algorithm on the signals obtained pre-cardioversion (in atrial fibrillation) and post-cardioversion (in sinus rhythm) from the novel smart-clothing form factor and the routine 12-lead ECG.
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