A Study to Evaluate Home Monitoring of Post-Discharge Congestive Heart Failure Patients

Overview

About this study

The primary purpose of this study is to collect long-term (2-month duration) data with the ADI CHF Device on patients at home to demonstrate effectiveness of the device in accurately measuring biologically relevant parameters and detecting fluid status as compared to the standard of care (weight scale).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Adults over the age of 21 and who are willing and able to give informed consent.
  • Willing to return for all follow-up visits and necessary medical care for duration of study (~8 weeks).
  • Diagnosed with CHF and have experienced >1 CHF event in the past 12 months.
  • Classified as NYHA Class I-IV within the past 12 months.
  • Have cellular coverage in their homes.
  • Fall within the 5th-95th percentile of chest circumference.

Exclusion Criteria: 

  • Under the age of 21.
  • Physical or cognitive limitations that would prevent patient from applying or using the device properly.
  • Women who are known to be pregnant or plan to become pregnant within the course of this study.
  • Has known allergies to silicone based adhesive or skin breakdown in areas where device placement is required.
  • Receiving dialysis with end-stage kidney disease.
  • Participant and his/her immediate family members work for a medical device or pharmaceutical company.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bruce Johnson, Ph.D.

Open for enrollment

Contact information:

Jennifer Isautier CCRP

(507)266-2696

Isautier.Jennifer@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20459066

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