NCT03826225

Brief Summary

This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to evaluate end-to-end performance of a cardiac monitor system and associated data management accessories.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 24, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 7, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

January 24, 2019

Last Update Submit

July 3, 2019

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Evaluate WCM System End-To-End Performance

    Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server

    3 months

Study Arms (1)

Study Cohort

All participants are considered to be in the study cohort and will have the study device placed externally on their skin in order to collect human ECG data.

Eligibility Criteria

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

This study will enroll volunteer adult participants who are employees of the study sponsor and who meet all eligibility criteria.

You may qualify if:

  • Willing and capable to provide informed consent
  • Age 18 or above
  • Employee of the study sponsor
  • Willing and able to follow protocol requirements

You may not qualify if:

  • Currently enrolled in another clinical study that interferes with data collection
  • Currently implanted with an active medical electronic device
  • Known allergies to the materials that may come in contact with the skin
  • Any active skin condition on the chest reported by the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Scientific

Saint Paul, Minnesota, 55112, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dave Perschbacher

    Senior R&D Fellow

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 24, 2019

First Posted

February 1, 2019

Study Start

March 7, 2019

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)