NCT07502599

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

Fainting Detection And Early Warning In Syncope Evaluation Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Orthostatic Hypotension
• Reflex Syncope

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2026-05-30
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2026-03-31
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States