Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

Kyma Medical Technologies

Status: Withdrawn

Conditions: Congestive Heart Failure

Treatments: Device: uCor

Study type: Interventional

Funder types: Industry

Identifiers

NCT02700191

PCL-72-030

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Control

No Intervention group

Description:

For subjects in the Control arm, the parameters measured by the (µ-Cor) µ-Cor system will not be analysed or made available to the investigator.

uCor

Experimental group

Description:

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.

Treatment:

Device: uCor