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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 August 2023
• Main ID: NCT02633644
• Date of registration: 15/12/2015
• Prospective Registration: No
• Primary sponsor: Enopace Biomedical
• Public title: Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)
• Scientific title: The Harmony System for the Treatment of Heart Failure Patients - A Safety and Performance Study
• Date of first enrolment: September 2015
• Target sample size: 30
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02633644
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, Croatia, Greece, Israel, Latvia

Contacts

• Name: Daniel Weiss, MD
• Affiliation: Enopace Biomedical

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: Harmony System

Primary Outcome(s)

The occurrence of all system and/or procedure related serious adverse events [Time Frame: 6 months]

Secondary Outcome(s)

The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI) [Time Frame: 6 months]

The change in echocardiographic assessment of left atrium volume index [Time Frame: 6 months]

The change in echocardiographic assessment of LV mass index [Time Frame: 6 months]

The change in echocardiographic assessment of LV end diastolic volume [Time Frame: 6 months]

The change in echocardiographic assessment of LV end systolic volume [Time Frame: 6 months]

The change in the exercise capacity as defined in a 6-minute walk test [Time Frame: 6 months]

The change in echocardiographic assessment of LV ejection fraction [Time Frame: 6 months]

The change in heart failure symptoms, as measured by quality of life, defined as an improvement from baseline on the Minnesota Living with Heart Failure® Questionnaire (MLWHFQ) [Time Frame: 6 months]

Secondary ID(s)

CL-250

Source(s) of Monetary Support

Please refer to primary and secondary sponsors