Heart Failure Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

60

Study ID:

NCT04609683

Recruitment Status:

Recruiting

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Langone Health
New York New York, 10016, United States More Info
Lior Jankelson
Contact
212-263-5555
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

60

Study ID:

NCT04609683

Recruitment Status:

Recruiting

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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