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OpenTrials
Completed

NCT Number: NCT03932227

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Hospital George Pompidou

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardioskin

Device

Subjects will have a 24h recording with Cardioskin, next will be unequipped.

Holter

Device

Subjects will have a 24h recording with Holter, next will be unequipped.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

BioSerenity

Industry

Registry information

Acronym: EVANI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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