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

This is a non-randomized feasibility study that will enroll up to 40 participants that have undergone a previous autonomic reflex screen (ARS) assessment and were either diagnosed with OH or reflex syncope or considered to be control subjects for this study.

A minimum of 20 subjects diagnosed with reflex syncope; a maximum of 15 subjects diagnosed with OH syncope and a maximum of 15 control subjects will be enrolled. There will be one in person study visit and a 21 day follow up period per subject.

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)