NCT02126631

Brief Summary

This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent 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 2014

Geographic Reach
1 country

1 active site

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

April 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

April 28, 2014

Last Update Submit

June 25, 2014

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. Diagnostic yield will also be assessed.

    24 hours of patient use, plus shipping and analysis time ~ 2 weeks

Secondary Outcomes (1)

  • Device comfort

    24 hours

Eligibility Criteria

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

Cardiac patients at Auckland City Hospital, Auckland, New Zealand

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 (1)

Auckland City Hospital

Auckland, 1142, New Zealand

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

  • Jon Hunt, PhD

    Bardy Diagnostics, Inc. (sponsor)

    STUDY DIRECTOR

  • Warren Smith, MBChB

    Auckland City Hospital

    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

April 28, 2014

First Posted

April 30, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

NZ(1)