Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial
Not Applicable
Withdrawn
- Conditions
- Congestive Heart Failure
- Interventions
- Device: uCor
- Registration Number
- NCT02700191
- Lead Sponsor
- Kyma Medical Technologies
- Brief Summary
Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Men or women 20-90 years old.
- New York Heart Association (NYHA) class III-IV heart failure
- Followed by the Congestive Heart Failure (CHF) clinic in Nazareth
- Left ventricular ejection fraction <35%
- Requiring treatment with >40mg/day of furosemide* orally or with repeated bolus or intravenous infusion of furosemide* (*or equivalent bumetanide or torasemide).
Exclusion Criteria
- Pregnancy
- Subjects who have received a heart transplant.
- Subjects who are unable or unwilling to follow the study requirements.
- Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- Patients with skin breakdown in areas on the chest where device and electrode placement is required
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description uCor uCor For subjects in the Interventional arm, all of the parameters measured by the (µ-Cor) µ-Cor system will be available to the investigator and will remain blinded to the subjects. The investigator will use µ-Cor information to aid in therapy adjustment decisions during the study period.
- Primary Outcome Measures
Name Time Method composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm. 30 days to 3 months
- Secondary Outcome Measures
Name Time Method