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Recruiting NCT07502599

Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)

— Observational Orthostatic Hypotension Reflex Syncope

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wearable holter monitor, Wearable holter monitor.
Who it may be relevant to
Registry conditions: Orthostatic Hypotension, Reflex Syncope. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Fainting Detection And Early Warning In Syncope Evaluation Study

Overview

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.

Interventions

  • Device Wearable holter monitor
    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.
  • Device Wearable holter monitor
    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.

Primary outcome measures

  • Physiologic Signal Detection via wearable holter monitor [Time frame: From enrollment through the 21 day follow up period]
Secondary outcome measures (1)
  • Physiologic Signal Detection via wearable holter monitor [Time frame: From enrollment through the 21 day follow up]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic Foundation — Rochester

Identifiers

NCT: NCT07502599 · C2232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗