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.

Study Overview

• Status: Completed
• Conditions: ECG Monitoring; Cardiac Patients

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Washington
    • Enumclaw, Washington, United States, 98022
      • EvergreenHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

cardiac patients followed at the study site's location

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adhesive performance/durability	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
human factors	Skin comfort or discomfort Device comfort Device stability and contact	7 days

Collaborators and Investigators

• Sponsor: Bardy Diagnostics, Inc.
• Investigators: Principal Investigator: Gene Trobaugh, MD, EvergreenHealth

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (ESTIMATE): May 8, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: 7 day study