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NCT04609683Completed

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

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

Source: ClinicalTrials.gov · Last updated 29 Nov 2023

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
19 (actual)
First submitted
22 Oct 2020
Start date
19 Sept 2022
Primary completion date
21 Nov 2022
Lead sponsor
NYU Langone Health
NCT number
NCT04609683

What you commit to

  • Study type: Interventional
  • Participants enrolled: 19
  • From 19 Sept 2022 to the primary completion date, 21 Nov 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.