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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 5 years ago
What is this trial about?
What are the participation requirements?
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