Status:
COMPLETED
Evaluation of the EasySense System in Congestive Heart Failure
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Institutes of Health (NIH)
University of Memphis
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
21+ years
Brief Summary
The EasySense device is a non-invasive device designed to measure lung fluid in patients with Congestive Heart Failure (CHF). This study seeks to evaluate the efficacy of the EasySense system in measu...
Detailed Description
Across the globe, Congestive Heart Failure (CHF) continues to be the leading cause of mortality and hospitalizations in the 21st century. Despite advancements, prognosis often remains poor and mortali...
Eligibility Criteria
Inclusion
- Current hospitalization for acute decompensated heart failure requiring IV diuretics or vasoactive drugs
- NYHA class II-IV
- Willing and able to participate in index and follow-up measurements
- Able to speak, read, and write in English
- Knows how to use a smartphone
- Preference for patients who undergo a right heart catheterization or continuous pulmonary artery monitoring upon admission or during hospitalization
Exclusion
- Current or planned treatments with any inotropic agents or mechanical support (LVAD, intra-aortic balloon pump, invasive mechanically assisted ventilation) at time of enrollment
- Requiring demand pacing
- Prior heart transplant
- End-stage renal disease on hemodialysis
- Physical deformities in the thorax area that may prevent proper application of EasySense device, as assessed by investigator
- Sign of local rib cage or thoracic lesion or any illness which may be aggravated or cause significant discomfort from application of EasySense device, as assessed by investigator
- Pregnancy or lactation
Key Trial Info
Start Date :
July 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03237923
Start Date
July 1 2017
End Date
June 30 2020
Last Update
February 5 2021
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210