Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

Congestive Heart Failure Clinical Trial

Official title:

Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02700191
• Other study ID #: PCL-72-030
• Status: Withdrawn
• Phase: N/A
• Start date: May 4, 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2020
• Source: Kyma Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• uCor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyma Medical Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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