Fainting Clinical Trials

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Fainting Detection And Early Warning In Syncope Evaluation Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Mayo Clinic Foundation
RECRUITING
Rochester
Contact Information
Primary
Ashley M Jensen, Masters of Science
ashley.jensen@bsci.com
612-449-2918
Backup
Mojgan Goftari, PhD
mojgan.goftari@bsci.com
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2028-08
Participants
Target number of participants: 40
Treatments
Syncope group
Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope
Control Group
Patients that have undergone an ARS assessment and are control subjects.
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov