Detecting Syncope by an Integrated Multisensor Patch-type Recorder (Patch-VD)

Istituto Auxologico Italiano

Status: Completed

Conditions: Syncope, Vasovagal

Treatments: Device: BP monitoring during tilt testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05782699

09C126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

patch monitoring

Experimental group

Treatment:

Device: BP monitoring during tilt testing

standard BP monitoring

Active Comparator group

Treatment:

Device: BP monitoring during tilt testing