Single-Lead Data Using Prototype Mome Arc 1-Lead Patch for Analysis Using Current Multi-Lead Algorithms.

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Outpatient Inclusion Criteria:

  • Adult persons 18 years of age and above.
  • Persons under evaluation for suspected, or known, cardiac arrhythmias and/or symptoms necessitating physician prescription of external cardiac monitoring and analysis.

Inpatient Inclusion Criteria:

  • Adult persons 18 years of age and above.
  • Patients admitted to hospital and currently undergoing continuous cardiac telemetry monitoring due to risk of arrhythmia or other cardiac issue.
  • Patients with capacity to consent to additional monitoring.

Outpatient Exclusion Criteria:

  • Patients who are at high risk of lethal arrhythmia.
  • Patients with unstable/undiagnosed significant cardiovascular disease with appropriate risk factors that rise to the level of high risk of cardiac events.
  • Patients with indications of syncope/pre-syncope and/or undifferentiated spells.
  • Patients with known skin sensitivities to widely utilized clinical ECG electrodes.
  • Patients with any implanted medical device such as a pacemaker, internal loop recorder, or deep brain stimulation device.
  • Patients with limited mobility and/or cognitive function requiring assisted outpatient care.

Inpatient Exclusion Criteria:

  • Patients with known skin sensitivities to widely utilized clinical ECG electrodes.
  • Patients that are unable to consent to additional data recording.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/14/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Abhishek Deshmukh, M.B.B.S.

Open for enrollment

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available