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
This trial does not accept healthy volunteersQualifiers
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 population
Patients that have previously undergone an ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Wearable holter monitor
DeviceParticipants will be fitted with a minimum of one wearable Holter monitor and up to 2 monitors, placed on the skin that measures physiologic signals. Participants will wear the monitor(s) for up approximately 21 days.
Wearable holter monitor
DeviceParticipants will be fitted with a minimum of one wearable Holter monitor and up to 2 monitors, placed on the skin that measures physiologic signals. Participants will wear the monitor(s) for up approximately 21 days.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Syncope group1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
Physiologic Signal Detection via wearable holter monitor
Blood pressure (mmHg) will be monitored in the clinic and ambulatory setting.
Time frame
From enrollment through the 21 day follow up periodSecondary outcomes
1
Physiologic Signal Detection via wearable holter monitor
Heart rate (bpm) will be monitored in the clinic and ambulatory setting.
Time frame
From enrollment through the 21 day follow upSponsors and contacts
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Source ClinicalTrials.gov