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

This study, called ARISE, is looking at how fainting spells (syncope) and low blood pressure when standing up (orthostatic hypotension) affect signals measured by a wearable Holter monitor. You would wear one or two Holter monitors on your skin for about 21 days. Researchers want to see if these monitors can detect changes in your body's signals related to these conditions and how those signals relate to your symptoms. This is an observational study, meaning no new treatments are being tested. We are looking for up to 40 participants who are 18 or older and have previously had an assessment for fainting or low blood pressure, or are healthy controls. The study status is currently unclear.

Study design: This is an observational study with up to 40 participants, including those with orthostatic hypotension, reflex syncope, and healthy controls. It is a non-randomized feasibility study.
What's involved: You would have one in-person visit and wear one or two wearable Holter monitors for approximately 21 days.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 21 days after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

Not specifiedAges 18+Observational

Boston Scientific Corporation

~40 participants

Updated 2026-08-12 on ClinicalTrials.gov

What's tested:Wearable holter monitor

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Physiologic Signal Detection via wearable holter monitor

Measured over From enrollment through the 21 day follow up period

Conditions

Orthostatic Hypotension

Reflex Syncope

Where it's being run

1 sites across 1 states

Minnesota1

Who to contact

Ashley M Jensen, Masters of Science

[email protected]

612-449-2918

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

Physiologic Signal Detection via wearable holter monitorFrom enrollment through the 21 day follow up period
Blood pressure (mmHg) will be monitored in the clinic and ambulatory setting.

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