Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02700191

Enrollment

Registered

2016-03-07

Start date

2016-05-04

Completion date

2016-12-31

Last updated

2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

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.

Interventions

DEVICEuCor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026