Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)

NCT07502599 — Recruiting, 40 participants, Boston Scientific Corporation

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Fainting Detection And Early Warning In Syncope Evaluation Study

RegistryNCT07502599, acronym ARISE
StatusRecruiting
Study typeObservational
Enrollment40 (Estimated)
SponsorBoston Scientific Corporation (Industry)
ConditionsOrthostatic Hypotension, Reflex Syncope
InterventionsWearable holter monitor (Device)
Datesstart 2026-08-06, primary completion 2028-09-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-03-31, last updated 2026-10-14
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Orthostatic Hypotension All trials for Reflex Syncope All trials of Wearable holter monitor

-Summary

To characterize the impact of orthostatic hypotension (OH) and Vasovagal syncope on signals measured using a wearable Holter monitor in the clinic and ambulatory setting.

To evaluate the relationship of signals measured from the Holter monitor with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.

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+Detailed description

This is a non-randomized feasibility study that will enroll up to 40 participants that have undergone a previous autonomic reflex screen (ARS) assessment and were either diagnosed with OH or reflex syncope or considered to be control subjects for this study.

A minimum of 20 subjects diagnosed with reflex syncope; a maximum of 15 subjects diagnosed with OH syncope and a maximum of 15 control subjects will be enrolled. There will be one in person study visit and a 21 day follow up period per subject.

+Arms and interventions

ArmTypeInterventionsDescription
Syncope groupDevice: Wearable holter monitorPatients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope
Control GroupDevice: Wearable holter monitorPatients that have undergone an ARS assessment and are control subjects.
  • Wearable holter monitor (Device): Participants will be fitted with a minimum of one wearable Holter monitor and up to 2 monitors, placed on the skin that measures physiologic signals. Participants will wear the monitor(s) for up approximately 21 days.
  • Wearable holter monitor (Device): Participants will be fitted with a minimum of one wearable Holter monitor and up to 2 monitors, placed on the skin that measures physiologic signals. Participants will wear the monitor(s) for up approximately 21 days.

+Outcome measures

Primary outcomes

  • Physiologic Signal Detection via wearable holter monitor [From enrollment through the 21 day follow up period]: Blood pressure (mmHg) will be monitored in the clinic and ambulatory setting.

Secondary outcomes

  • Physiologic Signal Detection via wearable holter monitor [From enrollment through the 21 day follow up]: Heart rate (bpm) will be monitored in the clinic and ambulatory setting.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Willing and capable to provide informed consent
* Age 18 or above
* Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing).
* Previously diagnosed with OH, Vasovagal syncope, OR control subjects assessed as normal, based on the ARS assessment. Participant enrollment shall be based on the type of diagnosis.
* Willing to complete all required study activities.

Exclusion Criteria:

* Currently enrolled in another clinical trial that might interfere with data collection.
* Subject is pregnant or planning to become pregnant during the study
* Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
* Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.
* Known allergy to materials used in the study (adhesive, ECG electrodes)
* Diagnosed with syncope due to cardiologic causes.
* Have had a myocardial infarction in the previous 90 days
* Have been diagnosed with tachycardia that requires current medical treatment
* Have any contraindications for exercise testing, tilt table test, Valsalva maneuver test or deep breathing test (judged by the study Principal Investigator)

+Locations (1)

FacilityCityCountryStatus
Mayo Clinic FoundationRochester, MinnesotaUnited StatesRecruiting