Study Stopped
The company shut down
Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)
The Harmony System for the Treatment of Heart Failure Patients - A Safety and Performance Study
1 other identifier
interventional
30
4 countries
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 heart-failure
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedJuly 28, 2023
July 1, 2023
7.8 years
December 15, 2015
July 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The occurrence of all system and/or procedure related serious adverse events
6 months
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
Treated with Harmony System
EXPERIMENTALImplantation and activation of the Harmony endovascular neurostimulator
Interventions
Eligibility Criteria
You may qualify if:
- Subject is diagnosed as chronic heart failure NYHA class II-III
- Subject should be receiving optimal medical treatment
- Subject signed and dated informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
OLV Hospital
Aalst, 9300, Belgium
University Hospital Center Zagreb
Zagreb, 10000, Croatia
Hippokration General Hospital
Athens, 11527, Greece
Rambam Healthcare Campus
Haifa, 3109601, Israel
Baruch Padeh Medical Center (Poriya)
Tiberias, 15208, Israel
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Daniel Weiss, MD
Enopace Biomedical
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2015
First Posted
December 17, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2023
Last Updated
July 28, 2023
Record last verified: 2023-07