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

Healthy Volunteers Clinical Trial

— EVANI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932227
• Other study ID #: 2019-A00922-55
• Status: Completed
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: BioSerenity
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Cardioskin
Subjects will have a 24h recording with Cardioskin, next will be unequipped.
• Holter
Subjects will have a 24h recording with Holter, next will be unequipped.

Locations

Country	Name	City	State
France	European Hospital George Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
BioSerenity

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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