PATCH-CT Study

Overview

About this study

The purpose of this study is to:

  1. Compare computer tomography (CT) determined lung fluid content with µCor Systems's thoracic fluid readings in patients with and without evidence of heart failure (HF).
  2. Observe the effect of location of the µCor System on the thoracic fluid readings.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

The following criteria will be used to include control subjects in the study:

  • Subjects with no evidence of acute decompensated heart failure; individuals with heart failure but are stable are eligible to participate as a control.
  • Subjects with no evidence of pulmonary congestion.
  • Subjects at least 21 years of age.
  • Subjects willing to undergo chest CT.

The following criteria will be used to include subjects with acute heart failure in the study:

  • Patients admitted with a diagnosis of an acute heart failure decompensation.
  • Patients with clinical evidence of pulmonary congestion prior to start of data collection.  Evidence of pulmonary congestion may include:  dyspnea, orthopnea, bendopnea, paroxysmal nocturnal dyspnea; tachypnea and hypoxia; auscultatory findings such as rales, crackles, wheezing; pathological chest radiography (interstitial/alveolar edema, pleural effusion); B-lines ("comets") on lung ultrasound.
  • Patients at least 21 years of age.
  • Patients willing to undergo chest CT.
  • At least 20 subjects (at least 10 subjects for phase 1) in New York Heart Association (NYHA) class IV heart failure at the start of their data collection. 

Exclusion Criteria:

  • Subjects in cardiogenic shock.
  • Subjects reporting or planning to be pregnant. 
  • Subjects with cardiac implantable electronic devices in an anatomical location that could lead to placement of the µCor system.  This includes allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesives. 
  • Employees of ZOLL or their family members.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Bruce Johnson, Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions