To increase familiarity with the biosensor and data derived from the sensor, we propose to measure TAVI patients in 3 different situations; 1) a measurement pre-TAVI in a home situation, 2) directly post-procedural inhospital and in the transition…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Aortic valve stenosis is accompanied with a high burden on mortality and
morbidity. A currently established treatment is the transcatheter aortic valve
implantation (TAVI). Identification for patients at risk for worse outcomes is
of importance. Remote monitoring in an out-of-hospital setting might objectify
frailty (vulnerability) and patients symptoms and therefore be beneficial in
clinical decision making. A better understanding of a patients (cardiac)
condition in combination with physical activity levels might provide better
insight in a patient risk profile and enables post procedural monitoring.
Recently wearable biosensors were developed in order to measure vital signs
combined with activity.
Study objective
To increase familiarity with the biosensor and data derived from the sensor, we
propose to measure TAVI patients in 3 different situations; 1) a measurement
pre-TAVI in a home situation, 2) directly post-procedural inhospital and in the
transition to home monitoring and 3) a follow-up measurement 6 weeks after the
procedure in a home situation. Measurements will be done each time point for 3
consecutive days. In a pilot study we will investigate whether a wearable
biosensor is able to quantify frailty and measure physical activity in relation
with heart rate, respiratory rate and ECG. Furthermore the ability to detect
and distinguish between conduction disorders will be investigated. A secondary
objective is to analyze whether the biosensor data will be sufficient to
monitor/screen for cardiac rhythm and conduction disorders to a level that the
care provider is comfortable sending patients home earlier or step down from
high-end cardiac telemetry. We will relate the sensor data to current standards
for frailty measurements.
Study design
Observational study
Study burden and risks
Data collection will be observational and non-invasive. Patients will wear an
adhesive patch and carry a smartphone device as relay for the data storage.
There are no specific instructions for patients to follow. No extra mandatory
visits to the hospital are planned.
In future we might be able to better measure frailty and investigate whether
monitoring patients with a wearable biosensor is feasible and the information
gathered aids the clinical decision making. The patient group (treatment of
aortic valve stenosis with a transcatheter aortic valve implantation) is
suitable for this research; there is currently no standard assessment for
frailty. Furthermore we are able in this patient group to monitor a variety of
cardiac diseases and co-morbidities.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
* 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61991.018.17 |