An interventional study of AleriTM sensors in Cardiac Arrhythmia, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic
Subjects will be consented to wear the AleriTM sensor prior to, during, and after an Electrophysiology Procedure. During this time, the system will measure the following parameters from subjects: HR, temperature, saline volume/rate, urine production volume, USG, BPO. Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor hydration levels of subjects compared to currently available methods.
Study subjects scheduled for an EP procedure who have signed an informed consent form (ICF) will be admitted to the study. Prior to the EP procedure (e.g. in a hospital room or operating room at NYU Medical Center), either an employee of NYU or Hydrostasis will place sensor on subject's bicep, forearm, or wrist, start the sensor and connect the sensor to mobile app to start data collection.
915 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's enrollment of 19 is below the median of 97 across 443 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
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Exclusion Criteria:
50 study subjects scheduled for an EP procedure will have AleriTM sensors on subject's bicep, forearm, or wrist, to start data collection. Measurements will be made from the subject for a period of approximately 1 hours prior to the EP procedure. . Measurements will continue as patient is moved to the operating room. Once the EP procedure is complete, the subject will be transferred from the operating room to a hospital room, where they will stay overnight. Measurements will be made for 3-5hours post-operation.Detailed analysis will investigate how does AleriTM data correlate with known measures such as saline volume/rate, urine production volume, USG, Blood osmolality and body weight;
Device: AleriTM sensors
AleriTM sensors are worn on the bicep or forearm and communicates through BLETM to a mobile App. The data is sent through the mobile App to web-based system processing where PHI is calculated and sent back to the mobile App. The AleriTM sensor has a form factor similar to a conventional arm band, with a hockey puck shape of approximately 48mm in diameter and 15mm in thickness the AleriTM sensor is a non-significant risk (NSR) device as it does not meet the definition of significant risk device (21 CFR 812.3(m)) because it is: not an implant; is not purported or represented to support or sustain human life; its use is not of substantial importance in the diagnosis, cure, treatment, mitigation, or prevention of impairment of health; and it does not present a serious risk to the health, safety, or welfare of a subject.
changes in body water content before, during and after an Electrophysiology Procedure
Study team will compare the hydration status (changes in body water content) as predicted by the Aleri sensor to changes in volume according to the routinely reported volume exchanges. This will be a correlation study, and as such the purpose would be to use Pearsons' correlation between the device measurement and the interval changes in fluids ingested or excreted by the patient. There is no benchmark, but rather we will be looking for statistically significant correlation for any r\>.5.
Time frame: 1 hour pre-surgery, during surgery and 3-5 hours post-surgery
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Lior.Jankelson@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Nov 2022, 2 months.
Of 154 non-industry interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 50. This study's 2 months is below that.
Counting every sponsor, half of 221 studies reached it within 28 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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