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

Sponsored by BioSerenity

About this trial

Last updated 5 years ago

Study ID

2019-A00922-55

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- people between 18 and 70 years old

No

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

Locations

Location

Status