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

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AleriTM sensors

Device

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.

Primary outcomes

changes in body water content before, during and after an Electrophysiology Procedure

Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Introductory Non-Clinical and Clinical Trial for Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Oct 30, 2020
Registry last updated: Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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