Z00-Z99
Conditions
Interventions
Group 1: Test device: LynxPatch
Names of reference devices:
12-channel ECG (ELI280, Mortara Instrument)
Echocardiogram (standard device at the test site)
Comparator ICG (CardioScreen 1000)
Digita
Sponsors
Lynx Health Science GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Provision of informed consent, i.e. the subject must be able to understand and sign the patient information and consent form. Group 1: Patients with planned cardiac examination Group 2: Patients with planned elective surgery
Exclusion criteria
Exclusion criteria: Subject is pregnant / breastfeeding Subject has compromised skin in the location where the LynxPatch is intended to be positioned Subject is in critical condition requiring intensive care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the accuracy measured as limit of agreement (LoA) of the heart rate from LynxPatch in comparison with the 12-lead-ECG. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are the accuracy, measured as limit of agreement (LoA) of the ECG parameters (except for HR) in comparison to 12-lead-ECG. In addition, qualitative assessment of ECG and stethoscope auscultation recording, performed by two independent physicians are included as secondary endpoints. | — |
Countries
Germany
Contacts
Public ContactAydan Ewers
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
Outcome results
None listed