BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

NCT ID: NCT02133261

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Cardiac Patients ECG Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bardy Diagnostics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gene Trobaugh, MD

Role: PRINCIPAL_INVESTIGATOR

EvergreenHealth

Locations

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EvergreenHealth

Enumclaw, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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7 day study

Identifier Type: -

Identifier Source: org_study_id

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