Clinical Trial Details

NCT ID: NCT02633644
Date Last Changed: December 22, 2015

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Harmony System for the treatment of Heart Failure (ENDO-HF)

Research Study Title

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

Purpose

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

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Enopace Biomedical
Duration
15 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

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

Site Locations (3)

Country State City Zip Facility and Contact
Belgium Aalst 9300 OLV Hospital
Croatia Zagreb 10000 University Hospital Center Zagreb
Latvia Riga 1002 Pauls Stradins Clinical University Hospital

Contact

Daniel Weiss, MD

E-mail:

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