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

Phase 2

Terminated

• Conditions: Heart Failure

• 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

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Primary Completion: 2023-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28

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

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 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 mass index	6 months
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 end diastolic volume	6 months
The change in echocardiographic assessment of left atrium volume index	6 months

Trial Locations

Locations (5)

OLV Hospital; 🇧🇪 Aalst, Belgium

University Hospital Center Zagreb; 🇭🇷 Zagreb, Croatia

Hippokration General Hospital; 🇬🇷 Athens, Greece

Rambam Healthcare Campus; 🇮🇱 Haifa, Israel

Baruch Padeh Medical Center (Poriya); 🇮🇱 Tiberias, Israel