BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

Completed

• Conditions: ECG Monitoring; Cardiac Patients

• Registration Number: NCT02133261
• Lead Sponsor: Bardy Diagnostics, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Status Verified: 2014-06
• Study Start: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adhesive performance/durability	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 Outcome Measures

Name	Time	Method
human factors	7 days	Skin comfort or discomfort Device comfort Device stability and contact

Trial Locations

Locations (1)

EvergreenHealth; 🇺🇸 Enumclaw, Washington, United States