NCT02133261

Completed

BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

Bardy Diagnostics, Inc.Source

Other study identifiers

Sponsor study identifier

7 day study

Study Type

observational

Actual enrollment (reported)

10

Locations

1 country

Sites

1

Timeline

Study Start

June 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2014

Actual (reported)

Study Completion

June 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 10 participants
Study completion date: June 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 6, 2014
Actual (reported)
First Posted
May 8, 2014
Actual (reported)
Study Start
June 2014
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)
Study Completion
June 2014
Actual (reported)

Last Updated: June 26, 2014
Status Verified: June 2014
Last Update Submitted: June 25, 2014

Conditions

Cardiac Patients ECG Monitoring

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

human factors
7 days

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

cardiac patients followed at the study site's location

You may qualify if:

cardiac patient volunteers (5 male and 5 female)

You may not qualify if:

Sponsors & Collaborators

Bardy Diagnostics, Inc.
Industrylead

Study Sites (1)

EvergreenHealth

Enumclaw, Washington, 98022, United States

Study Officials

Gene Trobaugh, MD
EvergreenHealth
PRINCIPAL INVESTIGATOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

June 2014

Date type not reported

This date has not been verified as actual or estimated.

Conventional Lead Opposed to Novel ECG (CLONE)

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Not ApplicableActive Not Recruiting

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The UK CAVIAR Study

Completed

skin rash or infection over the sternum
Sternal incision within 3 months from the date of enrollment

Contact the study team to confirm eligibility.

Primary Completion

June 2014

Actual (reported)

Study Completion

June 2014

Actual (reported)

Last Updated

June 26, 2014

Record last verified: 2014-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02133261
Data provider: ClinicalTrials.gov
Source updated: 2014-06-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:32 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations