CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:3/15/2019
Start Date:September 18, 2018
End Date:July 2030
Contact:Sean Snowden
Email:Sean_Snowden@edwards.com
Phone:949-250-1172

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A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

To establish the safety and effectiveness of the Edwards CENTERA Transcatheter Heart Valve
(THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at
intermediate operative risk for surgical aortic valve replacement (SAVR)

A prospective, single-arm, controlled, multicenter study. Additional subjects may be enrolled
in a bicuspid registry.

Inclusion Criteria:

1. Severe, calcific AS meeting the following transthoracic echocardiogram (TTE) criteria:
AV area ≤ 1.0 cm2 OR AV area index ≤ 0.6 cm2/m2, Jet velocity ≥ 4.0 m/s OR mean
gradient ≥ 40 mmHg

2. NYHA functional class ≥ II

3. Judged by the Heart Team to be at intermediate risk for open surgical therapy (i.e.,
predicted risk of surgical mortality ≥ 3% and < 8% at 30 days, based on the Society of
Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the
risk calculator)

4. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent as approved by the Institutional Review
Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring
is not an exclusion).

2. Known hypersensitivity to Nitinol (nickel or titanium)

3. Severe aortic regurgitation (> 3+)

4. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis

5. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant
procedure

6. Stroke or transient ischemic attack within 90 days of the valve implant procedure

7. Severe lung disease or currently on home oxygen

8. Severe pulmonary hypertension

9. History of cirrhosis or any active liver disease
We found this trial at
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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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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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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303 East Superior Street
Chicago, Illinois 60611
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43214
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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2500 Rocky Mountain Avenue
Loveland, Colorado 80538
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Morristown, New Jersey 07960
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Nashville, Tennessee 37205
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630 W 168th St
New York, New York
212-305-2862
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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Pittsburgh, Pennsylvania 15212
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Plano, Texas 75093
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Saint Louis, Missouri 63110
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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