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

NCT07502599 | Recruiting

• 1 other identifier: C2232
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthostatic Hypotension; Reflex Syncope

Keywords

tilt table test; valsalva

Outcome Measures

Primary Outcomes (1)

• Physiologic Signal Detection via wearable holter monitor

  Blood pressure (mmHg) will be monitored in the clinic and ambulatory setting.

  From enrollment through the 21 day follow up period

Secondary Outcomes (1)

• Physiologic Signal Detection via wearable holter monitor

  From enrollment through the 21 day follow up

Study Arms (2)

Syncope group

Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope

Device: Wearable holter monitor

Control Group

Patients that have undergone an ARS assessment and are control subjects.

Device: Wearable holter monitor

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.

Syncope group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have previously undergone an ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Hypotension, Orthostatic; Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ashley M Jensen, Masters of Science

CONTACT

612-449-2918; ashley.jensen@bsci.com

Mojgan Goftari, PhD

CONTACT

mojgan.goftari@bsci.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)