Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

NCT02700191 | Withdrawn

• 1 other identifier: PCL-72-030
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

NO INTERVENTION

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

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.

Device: uCor

Interventions

uCor DEVICE

uCor

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Zoll Medical Corporation: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 7, 2016
• Study Start: May 4, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share