Orthostatic HypotensionARISENCT07502599
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
An observational study of Orthostatic Hypotension and Reflex Syncope, run by Boston Scientific Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension, Reflex Syncope
- What is being tested?
- Wearable holter monitor
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have previously undergone an ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mojgan Goftari, PhD contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Foundation
Rochester, Minnesota, 55905
Wolfgang Singer, MD, singer.wolfgang@mayo.edu
Wolfgang Singer
About this study
Official title: Fainting Detection And Early Warning In Syncope Evaluation Study
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.
Read the detailed description
This is a non-randomized feasibility study that will enroll up to 40 participants that have undergone a previous autonomic reflex screen (ARS) assessment and were either diagnosed with OH or reflex syncope or considered to be control subjects for this study.
A minimum of 20 subjects diagnosed with reflex syncope; a maximum of 15 subjects diagnosed with OH syncope and a maximum of 15 control subjects will be enrolled. There will be one in person study visit and a 21 day follow up period per subject.
- Conditions
- Orthostatic Hypotension, Reflex Syncope
- Being tested
- Wearable holter monitor
- Keywords
- tilt table test, valsalva
- Medical subject headings
- Hypotension, Orthostatic, Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable holter monitorDevice
Participants 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 monitorDevice
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Syncope group | Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope Receives: Device: Wearable holter monitor | |
| Control Group | Patients that have undergone an ARS assessment and are control subjects. Receives: Device: Wearable holter monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic Signal Detection via wearable holter monitor
Blood pressure (mmHg) will be monitored in the clinic and ambulatory setting.
Measured: From enrollment through the 21 day follow up period
Secondary outcomes (1)
Physiologic Signal Detection via wearable holter monitor
Heart rate (bpm) will be monitored in the clinic and ambulatory setting.
Measured: From enrollment through the 21 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start6 Aug 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502599
- Sponsor's protocol ID
- C2232
- Acronym
- ARISE
- Status last verified
- Oct 2026
- First submitted
- 17 Mar 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy and confidentiality barriers in a small study population.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fainting Detection And Early Warning In Syncope Evaluation Study
- ClinicalTrials.gov ID
- NCT07502599
- Acronym / sponsor ID
- ARISE / C2232
- Conditions
- Orthostatic Hypotension, Reflex Syncope
- Keywords
- tilt table test, valsalva
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-randomized feasibility study that will enroll up to 40 participants that have undergone a previous autonomic reflex screen (ARS) assessment and were either diagnosed with OH or reflex syncope or considered to be control subjects for this study.
A minimum of 20 subjects diagnosed with reflex syncope; a maximum of 15 subjects diagnosed with OH syncope and a maximum of 15 control subjects will be enrolled. There will be one in person study visit and a 21 day follow up period per subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syncope group | – | Device: Wearable holter monitorPatients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope |
| Control Group | – | Device: Wearable holter monitorPatients that have undergone an ARS assessment and are control subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have previously undergone an ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable holter monitorParticipants 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. | Device | Syncope group |
| Wearable holter monitorParticipants 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. | Device | Control Group |
Primary outcome
Physiologic Signal Detection via wearable holter monitor
Time frame: From enrollment through the 21 day follow up period
Blood pressure (mmHg) will be monitored in the clinic and ambulatory setting.
1 secondary outcome
Physiologic Signal Detection via wearable holter monitor
Time frame: From enrollment through the 21 day follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy and confidentiality barriers in a small study population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mojgan Goftari, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Hypotension and Reflex Syncope, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley M Jensen, Masters of Science (612-449-2918, ashley.jensen@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiologic Signal Detection via wearable holter monitor (time frame: From enrollment through the 21 day follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.