Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure

Not Applicable

Completed

• Conditions: Cardiac Arrhythmia
• Interventions: Device: AleriTM sensors

• Registration Number: NCT04609683
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-10-30
• Study Start: 2022-09-19
• Primary Completion: 2022-11-21
• Status Verified: 2023-11
• Study Completion: 2023-11-05
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Patients with cardiac arrhythmias or other cardiac conditions that are scheduled for EP procedures.
• Subject is over 18 years of age at the time of consenting
• Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study

Exclusion Criteria

• Pregnant subjects
• Subjects who are participating in another clinical study that may affect the results of either study
• Subjects who are unwilling or unable to wear the sensor for a period of up to 14 hours
• Subjects who are considered by the principle investigator to be medically unsuitable for study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrostasis group	AleriTM sensors	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;

Primary Outcome Measures

Name	Time	Method
changes in body water content before, during and after an Electrophysiology Procedure	1 hour pre-surgery, during surgery and 3-5 hours post-surgery	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States