Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)

Enopace Biomedical

Status and phase: Terminated; Phase 2

Conditions: Heart Failure

Treatments: Device: Harmony System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02633644

CL-250

Details and patient eligibility

About

The purpose of the ENDO-HF study is to determine the safety & performance of the Harmony System for the treatment of heart failure

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is diagnosed as chronic heart failure NYHA class II-III
• Subject should be receiving optimal medical treatment
• Subject signed and dated informed consent

Exclusion criteria

• Subject has severe aortic sclerosis or calcification
• Subject diagnosed with severe aortic valve disease
• Subject has severe mitral stenosis
• Subject involved in any concurrent clinical investigation
• Subject with cerebral vascular accident or transient ischemic attack prior to enrollment
• Subject diagnosed with Marfan Syndrome
• Subject with moderate or severe chronic obstructive lung disease
• Subject is allergic to iodine or contrast media
• Subject with prior cardiac transplant or heart transplant candidate
• Subject with a life expectancy of less than 12 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treated with Harmony System

Experimental group

Description:

Implantation and activation of the Harmony endovascular neurostimulator

Treatment:

Device: Harmony System