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Wearable Monitor in Patients With Syncope (Watch-VD)

Primary Purpose

Syncope, Vasovagal

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
HeartGuide cuffless BP monitor
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syncope, Vasovagal focused on measuring Syncope, tilt testing, blood pressure monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Istituto Auxologico Italiano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cuffless BP monitoring

Beat-to-beat BP monitoring

Arm Description

Investigational device Omron HeartGuide® 6410T

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Compliance
Number of patients who will show failure of HeartGuide to measure BP during tilt event

Full Information

First Posted
March 11, 2023
Last Updated
March 23, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05782647
Brief Title
Wearable Monitor in Patients With Syncope
Acronym
Watch-VD
Official Title
Feasibility of Blood Pressure Measurement With a Wearable (Watch-type) Monitor in Patients With Syncope
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal
Keywords
Syncope, tilt testing, blood pressure monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cuffless (watch type) BP monitor and standard beat-to-beat monitoring device
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cuffless BP monitoring
Arm Type
Experimental
Arm Description
Investigational device Omron HeartGuide® 6410T
Arm Title
Beat-to-beat BP monitoring
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
HeartGuide cuffless BP monitor
Intervention Description
Wearable (watch-type) monitor: HeartGuide 6410T (Omron Healthcare, Kyoto, Japan)
Primary Outcome Measure Information:
Title
BP during event during tilt testing
Description
Difference between baseline (rest) BP and BP at the presyncopal event ("Delta BP slope") during tilt testing with HeartGuide and with control
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Compliance
Description
Number of patients who will show failure of HeartGuide to measure BP during tilt event
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IRCCS Istituto Auxologico Italiano
City
Milan
State/Province
MI
ZIP/Postal Code
16149
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available upon reasonable request to the principal investigator
IPD Sharing Time Frame
Aafter publication of the princiapl study
IPD Sharing Access Criteria
m.brignole@auxologico.it

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Wearable Monitor in Patients With Syncope

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