BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

ECG Monitoring Clinical Trial

Official title:

BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133261
• Other study ID #: 7 day study
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: June 25, 2014
• Start date: June 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Bardy Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Patients
• ECG Monitoring

Locations

Country	Name	City	State
United States	EvergreenHealth	Enumclaw	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bardy Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	human factors	Skin comfort or discomfort Device comfort Device stability and contact	7 days	No