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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02633644
• Other study ID #: CL-250
• Status: Terminated
• Phase: Phase 2
• Start date: September 2015

Study information

• Verified date: July 2023
• Source: Enopace Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Harmony System
Percutaneous neuromodulation of the aortic wall

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst
Croatia	University Hospital Center Zagreb	Zagreb
Greece	Hippokration General Hospital	Athens
Israel	Rambam Healthcare Campus	Haifa
Israel	Baruch Padeh Medical Center (Poriya)	Tiberias

Sponsors (1)

Lead Sponsor	Collaborator
Enopace Biomedical

Countries where clinical trial is conducted

Belgium,  Croatia,  Greece,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of all system and/or procedure related serious adverse events		6 months
Secondary	The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)		6 months
Secondary	The change in the exercise capacity as defined in a 6-minute walk test		6 months
Secondary	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
Secondary	The change in echocardiographic assessment of LV ejection fraction		6 months
Secondary	The change in echocardiographic assessment of LV end systolic volume		6 months
Secondary	The change in echocardiographic assessment of LV end diastolic volume		6 months
Secondary	The change in echocardiographic assessment of left atrium volume index		6 months
Secondary	The change in echocardiographic assessment of LV mass index		6 months