Wearable Monitor in Patients With Syncope

Study Overview
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Brief Summary
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The main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.

Detailed Description
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Background While ECG monitoring is a reliable and established method that allows to document bradycardia in a substantial proportion of patients affected by cardioinhibitory reflex syncope, the documentation of a transient hypotension is only seldom achieved in patients affected by hypotensive syncope. Conventional ambulatory blood pressure (BP) monitoring (ABPM) has important limitations due to the short period of monitoring (usually 24-48 hours) and the intermittent nature of BP measurements (usually every 15-20 min). The main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool. Method The study is a prospective intrapatient comparison during tilt testing between BP measured by mean of a wearable watch-type BP monitor (Omron HeartGuide 6410T, Omron Healthcare, Kyoto, Japan) and by mean of the standard methods for continuous finger BP monitoring (Finometer®, Finapres Medical Systems, Enchede, The Netherlands, and Task Force® monitor, CNSystem, Graz, Austria), based on the photoplethysmographic volume clamp method . Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the HeartGuide device and will be compared with the standard of reference of BP. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of impeding syncope (presyncope) or, alternatively at the time of maximum hypotensive effect, if syncope will not occur, and finally in the recovery period at the end of the test after returning in supine position.

Official Title
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Feasibility of Blood Pressure Measurement With a Wearable (Watch-type) Monitor in Patients With Syncope

Conditions
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Syncope, Vasovagal

Intervention / Treatment
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* Device: HeartGuide cuffless BP monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients, >18 years of age, referred for tilt testing because affected by suspected reflex syncope Exclusion Criteria: Arrhythmias or the inability of HeartGuide to measure BP supine at rest.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cuffless (watch type) BP monitor and standard beat-to-beat monitoring device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cuffless BP monitoring<br>Investigational device Omron HeartGuide® 6410T | Device: HeartGuide cuffless BP monitor<br>* Wearable (watch-type) monitor: HeartGuide 6410T (Omron Healthcare, Kyoto, Japan)<br>|
| Active Comparator: Beat-to-beat BP monitoring<br>Continuous finger BP monitoring (Finometer®, Finapres Medical Systems, Enchede, The Netherlands, and Task Force® monitor, CNSystem, Graz, Austria), based on the photoplethysmographic volume clamp method | Device: HeartGuide cuffless BP monitor<br>* Wearable (watch-type) monitor: HeartGuide 6410T (Omron Healthcare, Kyoto, Japan)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP during event during tilt testing | Difference between baseline (rest) BP and BP at the presyncopal event (Delta BP slope) during tilt testing with HeartGuide and with control | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Number of patients who will show failure of HeartGuide to measure BP during tilt event | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Syncope, tilt testing, blood pressure monitoring