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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Boston Scientific Corporation
Study ID
NCT07502599
Status
Recruiting
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Conditions

  • Orthostatic Hypotension
  • Reflex Syncope

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Mar 31, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Syncope group
    Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope
  • Arm: Control Group
    Patients that have undergone an ARS assessment and are control subjects.

Primary Outcome Measure

Physiologic Signal Detection via wearable holter monitor [ Time Frame: From enrollment through the 21 day follow up period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic FoundationRochesterMinnesota55905
Wolfgang Singer, MD
[email protected]
Wolfgang Singer (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By research site
Mayo Clinic Foundation· Rochester, MN

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