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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Harmony System
Sponsored by
Enopace Biomedical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Cardiovascular Diseases, Heart Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • OLV Hospital
  • University Hospital Center Zagreb
  • Hippokration General Hospital
  • Rambam Healthcare Campus
  • Baruch Padeh Medical Center (Poriya)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated with Harmony System

Arm Description

Implantation and activation of the Harmony endovascular neurostimulator

Outcomes

Primary Outcome Measures

The occurrence of all system and/or procedure related serious adverse events

Secondary Outcome Measures

The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)
The change in the exercise capacity as defined in a 6-minute walk test
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)
The change in echocardiographic assessment of LV ejection fraction
The change in echocardiographic assessment of LV end systolic volume
The change in echocardiographic assessment of LV end diastolic volume
The change in echocardiographic assessment of left atrium volume index
The change in echocardiographic assessment of LV mass index

Full Information

First Posted
December 15, 2015
Last Updated
July 26, 2023
Sponsor
Enopace Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT02633644
Brief Title
Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)
Official Title
The Harmony System for the Treatment of Heart Failure Patients - A Safety and Performance Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The company shut down
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2023 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enopace Biomedical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Cardiovascular Diseases, Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated with Harmony System
Arm Type
Experimental
Arm Description
Implantation and activation of the Harmony endovascular neurostimulator
Intervention Type
Device
Intervention Name(s)
Harmony System
Intervention Description
Percutaneous neuromodulation of the aortic wall
Primary Outcome Measure Information:
Title
The occurrence of all system and/or procedure related serious adverse events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)
Time Frame
6 months
Title
The change in the exercise capacity as defined in a 6-minute walk test
Time Frame
6 months
Title
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)
Time Frame
6 months
Title
The change in echocardiographic assessment of LV ejection fraction
Time Frame
6 months
Title
The change in echocardiographic assessment of LV end systolic volume
Time Frame
6 months
Title
The change in echocardiographic assessment of LV end diastolic volume
Time Frame
6 months
Title
The change in echocardiographic assessment of left atrium volume index
Time Frame
6 months
Title
The change in echocardiographic assessment of LV mass index
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Weiss, MD
Organizational Affiliation
Enopace Biomedical
Official's Role
Study Director
Facility Information:
Facility Name
OLV Hospital
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Hippokration General Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Rambam Healthcare Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Baruch Padeh Medical Center (Poriya)
City
Tiberias
ZIP/Postal Code
15208
Country
Israel

12. IPD Sharing Statement

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

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