Recruiting

Holter MonitorFainting Detection And Early Warning In Syncope Evaluation Study (ARISE)

Sponsor:

Boston Scientific Corporation

Code:

NCT07502599

Conditions

Orthostatic Hypotension

Reflex Syncope

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wearable holter monitor

Study Details

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

Study ID

NCT07502599

Start date

Aug 6, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Wearable holter monitor

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ashley M Jensen, Masters of Science

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

Mojgan Goftari, PhD

mojgan.goftari@bsci.com

Locations

Mayo Clinic Foundation

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Wolfgang Singer, MD

singer.wolfgang@mayo.edu

Principal Investigator:

Wolfgang Singer

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

tilt table test
valsalva

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.