I48.0 I48.1 I48.2
Conditions
Interventions
Group 1: The study is divided into three phases:
- The initial phase, in which the suitability of the patient is checked, data on demography and medical history are collected, and the electrodes of th
Sponsors
Hamberger Sanitary GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosis: Healthy (cohort 1 only), Atrial Fibrillation (cohort 2 only) or other Arrhythmias (cohort 3 only) - Other inclusion criterion: The subject may have cardiovascular preconditions, but must declare them.
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding women - Concurrent participation in another clinical trial - Individuals with nickel allergy - Individuals under the influence of alcohol or drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the signal quality of the prototype, in terms of determining by blinded evaluators whether the morphology with the prototype can be represented in sufficient quality to detect atrial fibrillation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the influence of physiological differences on the signal quality and interpretability of the EKG leads of the prototype. | — |
Countries
Germany
Contacts
Public ContactStephan Achenbach
Universitätsklinikum Erlangen, Medizin 2 - Kardiologie und Angiologie
Outcome results
None listed