aortic valve stenosis structural heart disease
Conditions
Interventions
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * In work-up for a TAVI * Age >18 years * Independent at home or help by informal care giver * Able to follow instructions of smartphone and measurement set-up * Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: * Patients with implanted devices (such as a pacemaker) are excluded from the study. * Patients with a damaged or very vulnerable skin around patch location * Patients with a known allergy to silicone or hydrocolloid adhesive materials * Patients with a cognitive impairment or inability to understand and follow-up instructions by the researcher and the smartphone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to investigate usability and feasibility of a wearable biosensor to monitor cardiac condition and for assessment of frailty and treatment effects in TAVI-patients in an out-of-hospital setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives address the following questions: 1. Assess reliability of biosensors output; a. Compare accuracy of the biosensors monolead ECG and vital parameters with the gold standard for ECG monitoring. b. Assess quality of biosensor activity measurements. c. Investigate the amount (as percentage of total measurement time) of analysable data in a continuous measurement 2. Investigate the relation of activity, heart rate, respiratory rate and other metrics from the biosensor with standardized frailty scales and treatment effects. 3. Investigate usefulness and accuracy of the biosensor monolead ECG for continuous monitoring of conduction disorders and retrospective analysis of ECG curves and trends. 4. Investigate the feasibility of the biosensor for patients and caregivers. | — |
Countries
The Netherlands
Outcome results
None listed