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

NCT ID: NCT02633644

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Brief Summary

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

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treated with Harmony System

Implantation and activation of the Harmony endovascular neurostimulator

Group Type EXPERIMENTAL

Harmony System

Intervention Type DEVICE

Percutaneous neuromodulation of the aortic wall

Interventions

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Harmony System

Percutaneous neuromodulation of the aortic wall

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enopace Biomedical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Weiss, MD

Role: STUDY_DIRECTOR

Enopace Biomedical

Locations

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OLV Hospital

Aalst, , Belgium

Site Status

University Hospital Center Zagreb

Zagreb, , Croatia

Site Status

Hippokration General Hospital

Athens, , Greece

Site Status

Rambam Healthcare Campus

Haifa, , Israel

Site Status

Baruch Padeh Medical Center (Poriya)

Tiberias, , Israel

Site Status

Countries

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Belgium Croatia Greece Israel

Other Identifiers

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CL-250

Identifier Type: -

Identifier Source: org_study_id

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