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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardioskin-Holter | Other | Subjects in the randomized group A, start by wear the Cardioskin during 24h, and after wear the Holter during 24h. |
|
| Holter-Cardioskin | Other | Subjects in the randomized group B, start by wear the Holter during 24h, and after wear the Cardioskin during 24h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioskin | Device | Subjects will have a 24h recording with Cardioskin, next will be unequipped. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| interpretability of signal for a fine analysis of cardiac repolarization | The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QRS width is measurable (answer "Yes" "No") | 48 hours |
| interpretability of signal for a fine analysis of cardiac repolarization |
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Inclusion Criteria:
Exclusion Criteria:
Polyamide - Polyester - Elastane - Other synthetic materials - Silicone - Silver
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Hospital George Pompidou | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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Monocentric, cross study, randomized
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| Holter | Device | Subjects will have a 24h recording with Holter, next will be unequipped. |
|
The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the T waves are visible (answer "Yes" "No") |
| 48 hours |
| interpretability of signal for a fine analysis of cardiac repolarization | The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the ST segment is analyzable (answer "Yes" "No") | 48 hours |
| interpretability of signal for a fine analysis of cardiac repolarization | The quality signal will be assess blindly by rythm specialists. For that, specialists will observe if the QT interval is measurable (answer "Yes" "No") | 48 hours |
| interpretability of signal for a fine analysis of cardiac repolarization | These cardiac observations will lead to a unique evaluation of the quality signal: either "interpretable" either "non-interpretable" (answer "Yes" "No") | 48 hours |
| evaluation of comfort | 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. | 24 hours |
| evaluation of usability | 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 | 24 hours |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |