NCT07502599 Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
| NCT ID | NCT07502599 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Orthostatic Hypotension |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2026-06 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07502599 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Orthostatic Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07502599 currently recruiting?
Yes, NCT07502599 is actively recruiting participants. Contact the research team at ashley.jensen@bsci.com for enrollment information.
Where is the NCT07502599 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07502599 clinical trial?
NCT07502599 is sponsored by Boston Scientific Corporation. The trial plans to enroll 40 participants.