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

  • Clinicaltrials.gov identifier

    NCT03932227

  • Recruitment Status

    Completed

  • First Posted

    April 30, 2019

  • Last update posted

    January 22, 2020

Study Description

Brief 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.

  • Condition or Disease:Healthy Volunteers
  • Intervention/Treatment: Device: Cardioskin
    Device: Holter
  • Phase: N/A

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 Design

  • Study Type: Interventional
  • Actual Enrollment: 39 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: Monocentric, cross study, randomized
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Other
  • Official Title: EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter
  • Actual Study Start Date: July 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: January 2020

Arms and interventions

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.

Outcome Measures

  • Primary Outcome Measures: 1. interpretability of signal [ Time Frame: 48 hours ]
    The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the isoelectric line is stable (answer "Yes" "No")
  • 2. interpretability of signal [ Time Frame: 48 hours ]
    The quality signal will be assess blindly by rythm specialists. For that,specialists will show the p waves are visible (answer "Yes" "No")
  • 3. interpretability of signal [ Time Frame: 48 hours ]
    The quality signal will be assess blindly by rythm specialists. For that,specialists will show if the R pic are visible (answer "Yes" "No")
  • 4. interpretability of signal [ Time Frame: 48 hours ]
    The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the RR intervals are visible (answer "Yes" "No")
  • 5. interpretability of signal [ Time Frame: 48 hours ]
    Cardiac observations will lead to a unique evaluation of the quality signal: either "interpretable" either "non-interpretable" (answer "Yes" "No")
  • Secondary Outcome Measures: 1. interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]
    The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QRS width is measurable (answer "Yes" "No")
  • 2. interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]
    The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the T waves are visible (answer "Yes" "No")
  • 3. interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]
    The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the ST segment is analyzable (answer "Yes" "No")
  • 4. interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]
    The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QT interval is measurable (answer "Yes" "No")
  • 5. interpretability of signal for a fine analysis of cardiac repolarization [ Time Frame: 48 hours ]
    These cardiac observations will lead to a unique evaluation of the quality signal: either "interpretable" either "non-interpretable" (answer "Yes" "No")
  • 6. evaluation of comfort [ Time Frame: 24 hours ]
    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.
  • 7. evaluation of usability [ Time Frame: 24 hours ]
    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

Eligibility Criteria

  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Locations

France
European Hospital George Pompidou
Paris

Sponsors and Collaborators

BioSerenity

More Information

  • Responsible Party: BioSerenity
  • ClinicalTrials.gov Identifier: NCT03932227 History of Changes
  • Other Study ID Numbers: 2019-A00922-55
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: January 22, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No