Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 17-010400
Sponsor Protocol Number: 90D0176
About this study
The purpose of this study is to:
- 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).
- Observe the effect of location of the µCor System on the thoracic fluid readings.
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.
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.
- 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
Mayo Clinic principal investigator
Bruce Johnson, Ph.D.
Closed for enrollment
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available