Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Wearable holter monitor
- Wearable holter monitor
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov