BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02133261

Enrollment

Registered

2014-05-08

Start date

2014-06-30

Completion date

2014-06-30

Last updated

2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Patients, ECG Monitoring

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results