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Detecting Syncope by an Integrated Multisensor Patch-type Recorder

Detection of Impending Reflex Syncope by Means of an Integrated Multisensor Patch-type Recorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05782699
Acronym
Patch-VD
Enrollment
50
Registered
2023-03-23
Start date
2021-06-25
Completion date
2022-05-31
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope, Vasovagal

Keywords

syncope, tilt table test, blood pressure monitoring

Brief summary

The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope during tilt testing.

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 cuffless patch 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 between BP measured by mean of a cuffless patch BP monitor (RootiRX System, Rooti Labs Ltd., Taipei, Taiwan) and by mean of the standard method during tilt testing. Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the RootiRX device and will be compared with the standard of reference. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of 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.

Interventions

DEVICEBP monitoring during tilt testing

BP measure at various times during tilt testing

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consecutive patients, * \>18 years of age, * referred for tilt testing because affected by suspected reflex syncope

Exclusion criteria

* Incapability to perform tilt testing

Design outcomes

Primary

MeasureTime frameDescription
BP pattern2 hoursDifference between baseline (rest) BP and BP at the (pre)syncopal event (Delta BP slope) during tilt testing with RootiRx and with standard method

Secondary

MeasureTime frameDescription
BP drop2 hoursAbsolute BP values during tilt event with RootiRx and with Finometer

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026