TELE-TAVI:<br>Usability of a wearable patch sensor in monitoring vital signs and activity in TAVI patients: a pilot study<br>

Completed

• Conditions: aortic valve stenosis; structural heart disease; 10082206

• Registration Number: NL-OMON47580
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-12
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to investigate usability and feasibility<br /><br>of a wearable biosensor to monitor cardiac condition and for assessment of<br /><br>frailty and treatment effects in TAVI-patients in an out-of-hospital setting.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives address the following questions:<br /><br>1. Assess reliability of biosensors output;<br /><br>a. Compare accuracy of the biosensors monolead ECG and vital parameters with<br /><br>the gold standard for ECG monitoring.<br /><br>b. Assess quality of biosensor activity measurements.<br /><br>c. Investigate the amount (as percentage of total measurement time) of<br /><br>analysable data in a continuous measurement<br /><br>2. Investigate the relation of activity, heart rate, respiratory rate and other<br /><br>metrics from the biosensor with standardized frailty scales and treatment<br /><br>effects.<br /><br>3. Investigate usefulness and accuracy of the biosensor monolead ECG for<br /><br>continuous monitoring of conduction disorders and retrospective analysis of ECG<br /><br>curves and trends.<br /><br>4. Investigate the feasibility of the biosensor for patients and caregivers.</p><br>