NCT02031484

Brief Summary

This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

January 8, 2014

Last Update Submit

October 5, 2016

Conditions

SyncopePresyncopePalpitationsAtrial FibrillationSupraventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

  • ECG signal quality

    ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings, using the following scale: Excellent, Good, Fair, Poor, Non-existent.

    14 days

Secondary Outcomes (1)

  • Device comfort

    14 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in Chicago, Charlotte, and Iowa under the care of a physician for symptoms listed in the inclusion criteria

You may qualify if:

  • Syncope of uncertain etiology or
  • Pre-syncope of uncertain etiology or
  • Palpitations of uncertain etiology or
  • Management of known AF/SVT patients

You may not qualify if:

  • Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
  • A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Iowa

Iowa City, Iowa, 52240, United States

Location

Mid Carolina Cardiology

Charlotte, North Carolina, 28204, United States

Location

Eastside Cardiology

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

SyncopeAtrial FibrillationTachycardia, Supraventricular

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesTachycardiaCardiac Conduction System Disease

Study Officials

  • Mark Kremers, MD

    Mid Carolina Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 9, 2014

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations

US(4)