Endovascular NeuromoDulation Treatment fOr Heart Failure... | NCT02633644

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

NCT02633644

Sponsor

Enopace Biomedical

Status

Terminated

Last Update Posted

Jul 28, 2023Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Heart Failure

Interventions

Harmony System

Countries

Belgium
Croatia
Greece
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The company shut down

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jun 2023Actual

Completion Date

Not provided

First Submitted Date

Dec 15, 2015

First Submission Date that Met QC Criteria

Dec 15, 2015

First Posted Date

Dec 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2023

Last Update Posted Date

Jul 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treated with Harmony System	Experimental	Implantation and activation of the Harmony endovascular neurostimulator	Device: Harmony System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Harmony System	Device	Percutaneous neuromodulation of the aortic wall	Treated with Harmony System

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)		6 months
The change in the exercise capacity as defined in a 6-minute walk test		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Weiss, MD	Enopace Biomedical	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OLV Hospital		Aalst		9300	Belgium
University Hospital Center Zagreb

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided