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Clinical Trials in the USA / NCT07502599
Recruiting Observational

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

NCT07502599 · tracked via the Priya Life Science USA tracker
Sponsor
Boston Scientific Corporation
Phase
Observational
Started
2026-08-06
Last updated
2026-09-09

Condition(s) studied

Orthostatic HypotensionReflex Syncope

Investigational drug(s) / intervention(s)

Wearable holter monitorWearable holter monitor

Wearable holter monitor: 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: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Mayo Clinic Foundation Rochester Minnesota Recruiting

More Boston Scientific Corporation trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07502599 on ClinicalTrials.gov ↗ ← All trials in the USA