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EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter

NCT03932227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-01-22

No results posted yet for this study

Summary

The aim is to evaluate the electrocardiogram quality signal of the Cardioskin device and compare it with a Holter signal. For that, volunteers subjects will wear the Cardioskin and Holter, non-simultaneously, for about 24 hours.

This study is open, and will be carried out according to a cross plan. The trial will include approximately 36-40 subjects between 18 and 70 years old.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

Cardioskin

Subjects will have a 24h recording with Cardioskin, next will be unequipped.

DEVICE

Holter

Subjects will have a 24h recording with Holter, next will be unequipped.

Sponsors & Collaborators

  • BioSerenity

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03932227 on ClinicalTrials.gov