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JenaValve Pericardial TAVR System Aortic Stenosis Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02732691
First Posted: April 11, 2016
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
JenaValve Technology, Inc.
  Purpose
The purpose of this research study is to collect information about a new treatment for severe aortic stenosis, which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Condition Intervention
Aortic Stenosis Device: JenaValve Pericardial TAVR System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness/Performance of the Transapical and Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)

Resource links provided by NLM:


Further study details as provided by JenaValve Technology, Inc.:

Primary Outcome Measures:
  • All-Cause Mortality at 30 Days [ Time Frame: 30 days ]
    All-Cause Mortality Rate at 30 Days


Secondary Outcome Measures:
  • Event rate of VARC-2 Individual Safety Endpoints [ Time Frame: 2 to 5 years ]

    Event rate of VARC-2 individual safety endpoints procedurally to 30 days, 6 months, 1 year and annually up to 5 years (US) and 2 years (OUS) for the following:

    • All-cause mortality
    • Myocardial infarction
    • Neurological Complications - All-cause stroke and transient ischemic attack (TIA)
    • Bleeding Complications
    • Acute kidney injury (AKI classification within 7 days post-index procedure)
    • Vascular Complications (Major, minor, closure device failure)
    • Conduction Disturbances and Arrhythmias
    • TAVR-related complications

  • Clinical Outcomes through 5 years (US) and to 2 year follow-up (OUS) - 6MWT [ Time Frame: 2 to 5 years ]

    Number of patients with improvement vs. baseline in symptoms measured by

    - Improvement vs. baseline in functional status using six minute walk test (6MWT) improvement greater than 50 feet from baseline


  • Clinical Outcomes through 5 years (US) and to 2 year follow-up (OUS) - KCCQ [ Time Frame: 2 to 5 years ]

    Number of patients with improvement vs. baseline in symptoms measured by

    - Improvement vs. baseline in Quality of Life, per Kansas City Cardiomyopathy Questionnaire (KCCQ greater than 10 from baseline)


  • Clinical Outcomes through 5 years (US) and to 2 year follow-up (OUS) - NYHA Class [ Time Frame: 2 to 5 years ]

    Number of patients with improvement vs. baseline in symptoms measured by

    - NYHA Class greater than 1 over baseline, or NYHA Class less than III or IV



Other Outcome Measures:
  • Device Success [ Time Frame: Discharge through 1 year (OUS) to 5 Years (US) ]
    Number of patients alive and stroke-free with the originally intended device in place, with no surgical or interventional procedure related to access or the device, and with the device performing as intended.


Estimated Enrollment: 60
Actual Study Start Date: February 2016
Estimated Study Completion Date: September 2023
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transcatheter aortic valve replacement
In this study, transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using the JenaValve delivery system.
Device: JenaValve Pericardial TAVR System
In this study, transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using the JenaValve delivery system.

Detailed Description:
This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. The TAVR procedure is performed by a heart surgeon and/or an interventional cardiologist. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using the JenaValve delivery system. The JenaValve replacement valve may be implanted in one of two ways: (1) transapical - where the valve is implanted through the chest wall, and (2) transfemoral - where the valve is implanted through an artery in the groin. The choice of which implant method will be used is decided by the doctor. The choice of which approach is used is at the clinical discretion of the study physicians. The TAVR procedure typically takes 1-2 hours to complete. The JenaValve TAVR device, once implanted, is designed to remain permanently in place.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with severe degenerative native aortic stenosis (AS).
  • Patient at high risk for open surgical valve replacement
  • Patient symptomatic according to NYHA functional class II or higher

Exclusion Criteria:

  • Congenital uni- or bicuspid aortic valve morphology
  • Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
  • Endocarditis or other active infection
  • Need for urgent or emergent TAVR procedure for any reason
  • Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732691


Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, District of Columbia
MedStar Washington Hospital Center
Washington, D.C., District of Columbia, United States, 20010
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Germany
Klinikum Augsburg
Augsburg, Germany, 86156
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Univiersitäts Herzzentrum Freiburg Bad Krozingen
Freiburg, Germany, 79106
Universitätsklinikum Halle
Halle (Saale), Germany, 6120
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 20246
Herzzentrum der Universität zu Köln
Köln, Germany, 50937
Robert-Bosch- Krankenhaus Stuttgart
Stuttgart, Germany, 70376
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300
St. Antonius Hospital
Nieuwegein, Netherlands, 1105
Erasmus University Medical Center
Rotterdam, Netherlands, 3000
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Waikato Hospital
Hamilton, New Zealand, 3210
Sponsors and Collaborators
JenaValve Technology, Inc.
Cardiovascular Research Foundation, New York
Investigators
Study Chair: Martin B Leon, MD NewYork-Presbyterian/Columbia University Medical Center
Principal Investigator: Susheel Kodali, MD Columbia University
Principal Investigator: Vinod Thourani, MD Emory University
Principal Investigator: Hendrik Treede, MD Universitätsklinikum Halle
  More Information

Responsible Party: JenaValve Technology, Inc.
ClinicalTrials.gov Identifier: NCT02732691     History of Changes
Other Study ID Numbers: CP-0003
P02C220_JV06EFS_CIP ( Other Identifier: JenaValve Technology Inc. )
CA-0001 EU ( Other Identifier: JenaValve Technology Inc. )
CA-0001 Germany ( Other Identifier: JenaValve Technology Inc. )
CA-0010 ( Other Identifier: JenaValve Technology Inc. )
First Submitted: March 18, 2016
First Posted: April 11, 2016
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by JenaValve Technology, Inc.:
Aortic Valve Disease
Aortic Valve Stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction