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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02633644

Enrollment

Registered

2015-12-17

Start date

2015-09-30

Completion date

Unknown

Last updated

2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Cardiovascular Diseases, Heart Diseases

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

Interventions

DEVICEHarmony System

Percutaneous neuromodulation of the aortic wall

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The occurrence of all system and/or procedure related serious adverse events	6 months

Secondary

Measure	Time frame
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 the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)	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
The change in echocardiographic assessment of LV end systolic volume	6 months

Countries

Belgium, Croatia, Greece, Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026