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

July 26, 2023 updated by: Enopace Biomedical

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • OLV Hospital
  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Center Zagreb
  • Greece
      • Athens, Greece, 11527
        • Hippokration General Hospital
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Healthcare Campus
      • Tiberias, Israel, 15208
        • Baruch Padeh Medical Center (Poriya)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated with Harmony System
Implantation and activation of the Harmony endovascular neurostimulator
Device: Harmony System
Percutaneous neuromodulation of the aortic wall

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enopace Biomedical

Investigators

  • Study Director: Daniel Weiss, MD, Enopace Biomedical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimated)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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