BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

Bardy Diagnostics

Status: Completed

Conditions: Cardiac Patients; ECG Monitoring

Study type: Observational

Funder types: Industry

Identifiers

NCT02133261

7 day study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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