NCT03932227

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: BioSerenity · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-08
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-04-30
• Last updated: 2020-01-22

Locations

1 site across 1 country: France