Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

NCT ID: NCT02700191

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-04
• Study Completion Date: 2016-12-31

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

uCor

Intervention Type: DEVICE

Interventions

uCor

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zoll Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PCL-72-030

Identifier Type: -

Identifier Source: org_study_id