Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Fainting Detection And Early Warning In Syncope Evaluation Study
Boston Scientific Corporation
40 participants
Jun 1, 2026
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07502599