JenaValve Pericardial TAVR System Aortic Stenosis Study



Status:Enrolling by invitation
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:February 2016
End Date:September 2024

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Safety and Effectiveness/Performance of the Transapical and Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)

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.

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.

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
We found this trial at
6
sites
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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from
Berlin,
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Washington, District of Columbia
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Washington,
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