Clinical Trial

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

Study acronym: ARISE
Recruiting
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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.
Protocol Amendment History 5 changes
notable Primary completion pushed: 2028-08 -> 2028-09 2026-07-16
minor Completion pushed: 2028-08 -> 2028-09 2026-07-16
critical Recruitment opened 2026-06-18
notable Primary completion pushed: 2028-07 -> 2028-08 2026-05-15
minor Completion pushed: 2028-07 -> 2028-08 2026-05-15
Trial Details
NCT Number NCT07502599
Lead Sponsor Boston Scientific Corporation
Conditions Orthostatic Hypotension, Reflex Syncope
Enrollment 40 participants
Start Date 2026-08-06
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-12