EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter
EVANI
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy-volunteers
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedStudy Start
First participant enrolled
July 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 22, 2020
January 1, 2020
6 months
April 19, 2019
January 21, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
interpretability of signal
The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the isoelectric line is stable (answer "Yes" "No")
48 hours
interpretability of signal
The quality signal will be assess blindly by rythm specialists. For that,specialists will show the p waves are visible (answer "Yes" "No")
48 hours
interpretability of signal
The quality signal will be assess blindly by rythm specialists. For that,specialists will show if the R pic are visible (answer "Yes" "No")
48 hours
interpretability of signal
The quality signal will be assess blindly by rythm specialists. For that,specialists will show is the RR intervals are visible (answer "Yes" "No")
48 hours
interpretability of signal
Cardiac observations will lead to a unique evaluation of the quality signal: either "interpretable" either "non-interpretable" (answer "Yes" "No")
48 hours
Secondary Outcomes (7)
interpretability of signal for a fine analysis of cardiac repolarization
48 hours
interpretability of signal for a fine analysis of cardiac repolarization
48 hours
interpretability of signal for a fine analysis of cardiac repolarization
48 hours
interpretability of signal for a fine analysis of cardiac repolarization
48 hours
interpretability of signal for a fine analysis of cardiac repolarization
48 hours
- +2 more secondary outcomes
Study Arms (2)
Cardioskin-Holter
OTHERSubjects in the randomized group A, start by wear the Cardioskin during 24h, and after wear the Holter during 24h.
Holter-Cardioskin
OTHERSubjects in the randomized group B, start by wear the Holter during 24h, and after wear the Cardioskin during 24h.
Interventions
Subjects will have a 24h recording with Cardioskin, next will be unequipped.
Subjects will have a 24h recording with Holter, next will be unequipped.
Eligibility Criteria
You may qualify if:
- people between 18 and 70 years old
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioSerenitylead
Study Sites (1)
European Hospital George Pompidou
Paris, 75015, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2019
First Posted
April 30, 2019
Study Start
July 8, 2019
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
January 22, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share