EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter (EVANI)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Cardioskin; Device: Holter

Detailed Description

The wear of the first device will be randomized. Each subject will wear the two devices.

One group will start with a 24-hour environmental recording with Cardioskin and then will perform another recording of about 24 hours with the Holter. Conversely, group B will start with the Holter and then will continue with Cardioskin. It is a randomization software that will assign a group to each included participant.

Each participant will come three times at hospital : one for inclusion and equipment of the first device, another to be unequipped and equipped of the second device. They will come another time to bring back the material. The total time of participation is of two days and half.

The first aim is to evaluate if the signal interpretability is non-inferior to an Holter, for a recording of 24h (classic analysis of rhythm).

The second aim is to evaluate if the 24 hours signal interpretability is non-inferior to an Holter in the case of a repolarization analysis.

The third aim is to compare the comfort and usability between Cardioskin and Holter.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • European Hospital George Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• people between 18 and 70 years old

Exclusion Criteria:

• Minors
• Pregnant, parturient or breastfeeding women
• Refusal of consent
• Participant with known cardiac history
• Participant with cardiac arrhythmia observed during control ECG
• Participant who may be exposed to ionizing or electromagnetic radiation on days when devices (Cardioskin, Holter) will be worn
• Allergy to one of the components of the Cardioskin T-shirt, including:

Polyamide - Polyester - Elastane - Other synthetic materials - Silicone - Silver

• Allergy to one of the components of the electrodes used for the Holter (Kendall 530 or similar)
• Sensory disturbances that make the participant unresponsive to pain
• Motor or mental disorders that prevent the participant from expressing their pain -Behavioral problems that make the participant excessively Agitated or Aggressive
• Cardiorespiratory disorders that may be aggravated by mild compression of the chest
• Weight and / or size not suitable for the proposed Cardioskin T-shirt designs
• Open wound on the skin in the area covered by Cardioskin textile or by the electrodes of the Holter
• Irritation, and / or erythema in the area covered by the Cardioskin textile or by the electrodes of the Holter
• Pregnancy clinically detectable or known to a participant
• Participant with a high infectious risk
• Person wearing breast prostheses
• Simultaneous participation in another search

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cardioskin-Holter; Subjects in the randomized group A, start by wear the Cardioskin during 24h, and after wear the Holter during 24h.	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.
Other: Holter-Cardioskin; Subjects in the randomized group B, start by wear the Holter during 24h, and after wear the Cardioskin during 24h.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interpretability of signal	The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the isoelectric line is stable (answer "Yes" "No")	48 hours
interpretability of signal	The quality signal will be assess blindly by rythm specialists. For that,specialists will show the p waves are visible (answer "Yes" "No")	48 hours
interpretability of signal	The quality signal will be assess blindly by rythm specialists. For that,specialists will show if the R pic are visible (answer "Yes" "No")	48 hours
interpretability of signal	The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the RR intervals are visible (answer "Yes" "No")	48 hours
interpretability of signal	Cardiac observations will lead to a unique evaluation of the quality signal: either "interpretable" either "non-interpretable" (answer "Yes" "No")	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interpretability of signal for a fine analysis of cardiac repolarization	The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QRS width is measurable (answer "Yes" "No")	48 hours
interpretability of signal for a fine analysis of cardiac repolarization	The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the T waves are visible (answer "Yes" "No")	48 hours
interpretability of signal for a fine analysis of cardiac repolarization	The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the ST segment is analyzable (answer "Yes" "No")	48 hours
interpretability of signal for a fine analysis of cardiac repolarization	The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QT interval is measurable (answer "Yes" "No")	48 hours
interpretability of signal for a fine analysis of cardiac repolarization	These cardiac observations will lead to a unique evaluation of the quality signal: either "interpretable" either "non-interpretable" (answer "Yes" "No")	48 hours
evaluation of comfort	At the end of each recording, a subject will answer to a questionnary For comfort of the textile: Score of 0 to 70 points where 0 is comfortable and 70 is not comfortable.	24 hours
evaluation of usability	At the end of each recording, a subject will answer to a questionnary For usability of the system: score of 0 to 100 points where 0 is a bad usability and 100 is excellent	24 hours

Collaborators and Investigators

• Sponsor: BioSerenity

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-A00922-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No