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OpenTrials
Completed

NCT Number: NCT02133261

BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.

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Key information

Conditions

Cardiac Patients ECG Monitoring

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

EvergreenHealth

Enumclaw, Washington, 98022, United States

About this study

The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cardiac patient volunteers (5 male and 5 female)

Exclusion criteria

  • skin rash or infection over the sternum
  • Sternal incision within 3 months from the date of enrollment

Treatment and study plan

Primary outcomes

  1. adhesive performance/durability

    Time frame: 7 days

    The study will evaluate adhesive performance/durability by evaluating the Signal Quality of ECG data on the subjects (5 men and 5 women) in accordance with the requirements of FDA's ECG Electrode Guidance (section 5.A.3)1 and the ANSI/AAMI EC-12 Disposable ECG electrode technical standard (sections 4.4 and 5.4)2.

Secondary outcomes

  1. human factors

    Time frame: 7 days

    Skin comfort or discomfort Device comfort Device stability and contact

Sponsors and collaborators

Lead sponsor

Bardy Diagnostics, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 8, 2014
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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