Data Collection - Of Syncope Tilt Table Testing Study (NCT03721393) | Clinical Trial Compass
CompletedNot Applicable
Data Collection - Of Syncope Tilt Table Testing Study
United States50 participantsStarted 2019-10-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing and capable to provide informed consent
* Age 18 or above
* No contraindications to undergo tilt table test, Valsalva maneuver test, and deep breathing test (Components of the ARS assessment)
* Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing). Previously diagnosed with OH, reflex syncope, OR control subjects assessed as normal, based on the ARS assessment. Patient enrollment shall be based on the type of diagnosis.
* Willing to participate in one additional tilt table test, Valsalva maneuver test, and deep breathing test (components of the ARS assessment)
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 medical treatment
* Experienced complications during pre…