Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)
Phase 2
Terminated
- Conditions
- Heart Failure
- Interventions
- Device: Harmony System
- Registration Number
- NCT02633644
- Lead Sponsor
- Enopace Biomedical
- Brief Summary
The purpose of the ENDO-HF study is to determine the safety \& performance of the Harmony System for the treatment of heart failure
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treated with Harmony System Harmony System Implantation and activation of the Harmony endovascular neurostimulator
- Primary Outcome Measures
Name Time Method The occurrence of all system and/or procedure related serious adverse events 6 months
- Secondary Outcome Measures
Name Time Method The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI) 6 months The change in echocardiographic assessment of LV ejection fraction 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 end diastolic volume 6 months The change in echocardiographic assessment of LV end systolic volume 6 months The change in echocardiographic assessment of LV mass index 6 months The change in echocardiographic assessment of left atrium volume index 6 months
Trial Locations
- Locations (5)
OLV Hospital
🇧🇪Aalst, Belgium
Baruch Padeh Medical Center (Poriya)
🇮🇱Tiberias, Israel
University Hospital Center Zagreb
🇭🇷Zagreb, Croatia
Hippokration General Hospital
🇬🇷Athens, Greece
Rambam Healthcare Campus
🇮🇱Haifa, Israel