Syncope, Vasovagal Clinical Trial
— Patch-VDOfficial title:
Detection of Impending Reflex Syncope by Means of an Integrated Multisensor Patch-type Recorder
NCT number | NCT05782699 |
Other study ID # | 09C126 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 25, 2021 |
Est. completion date | May 31, 2022 |
Verified date | March 2023 |
Source | Istituto Auxologico Italiano |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Istituto Auxologico Italiano | Milan | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Auxologico Italiano |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BP pattern | Difference between baseline (rest) BP and BP at the (pre)syncopal event ("Delta BP slope") during tilt testing with RootiRx and with standard method | 2 hours | |
Secondary | BP drop | Absolute BP values during tilt event with RootiRx and with Finometer | 2 hours |
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