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

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

Official Title
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The Harmony System for the Treatment of Heart Failure Patients - A Safety and Performance Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Harmony System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated with Harmony System<br>Implantation and activation of the Harmony endovascular neurostimulator | Device: Harmony System<br>* Percutaneous neuromodulation of the aortic wall<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of all system and/or procedure related serious adverse events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI) |  | 6 months | 
| The change in the exercise capacity as defined in a 6-minute walk test |  | 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) |  | 6 months | 
| The change in echocardiographic assessment of LV ejection fraction |  | 6 months | 
| The change in echocardiographic assessment of LV end systolic volume |  | 6 months | 
| The change in echocardiographic assessment of LV end diastolic volume |  | 6 months | 
| The change in echocardiographic assessment of left atrium volume index |  | 6 months | 
| The change in echocardiographic assessment of LV mass index |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cardiovascular Diseases, Heart Diseases