JenaValve Pericardial TAVR Aortic Regurgitation Study



Status:Enrolling by invitation
Healthy:No
Age Range:18 - Any
Updated:11/10/2018
Start Date:April 2016
End Date:July 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 Regurgitation (AR)

The purpose of this research study is to collect information about a new treatment for severe
aortic regurgitation, which affects the aortic valve in the heart. Aortic regurgitation is a
condition where the heart's aortic valve does not close tightly and allows some blood to leak
back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and
shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve
replacement surgery.

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a
minimally invasive procedure designed to replace the aortic valve inside the heart. The
JenaValve Pericardial TAVR System will be examined in this clinical study for aortic valve
replacement. The TAVR procedure is performed by a heart surgeon and/or an interventional
cardiologist. A 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 regurgitation. 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 aortic regurgitation (AR).

- 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
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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Berlin,
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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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Washington, District of Columbia
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Washington,
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