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To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.
To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.
This is a non-randomized feasibility study that will enroll up to 50 participants that have undergone a previous autonomic reflect screen (ARS) assessment and were either diagnosed with OH or reflex syncope, or considered to be control subjects for this study.
A maximum of 20 subjects diagnosed with reflex syncope, a maximum of 10 subjects diagnosed with OH and a maximum of 10 control subjects will be enrolled. There will be one study visit per subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Syncope patients | Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope. |
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| Group 2: Control patients | Patients that have undergone an ARS assessment and are control subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable heart monitor | Device | Participants will be fitted with a wearable heart monitor placed on the skin that measures physiologic signals. There is no intervention or treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Signal Detection | Characterize the impact of orthostatic hypotension (OH) and reflex syncope on physiologic signals measured using a wearable cardiac monitor prototype device. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that have previously undergone a ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects.
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Singer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Foundation | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D019462 | Syncope, Vasovagal |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |