The PARTNER 3 - AVIV Trial



Status:Recruiting
Conditions:Cardiology, Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:19 - Any
Updated:12/6/2018
Start Date:January 5, 2017
End Date:March 5, 2027
Contact:Justine Encabo
Email:Justine_Encabo@edwards.com
Phone:949-250-3502

Use our guide to learn which trials are right for you!

P3-AVIV is a Prospective, Single-arm, Multicenter Clinical Trial That Will Establish the Safety and Efficacy of SAPIEN 3 THV in Patients With a Failing Aortic Bioprosthetic Valve

To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,
California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a
failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating
stenosis and/or insufficiency.

Inclusion Criteria:

1. Failing surgical or transcatheter bioprosthetic valve in the aortic position
demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

2. Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.

3. NYHA Functional Class ≥ II.

4. Heart Team agrees valve implantation will likely benefit the patient.

5. The study patient 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 (IRB) of the respective clinical site.

Exclusion Criteria:

1. Surgical or transcatheter valve in the mitral position (mitral rings are not an
exclusion).

2. Severe regurgitation (>3+) or stenosis of any other valve.

3. Failing valve has paravalvular regurgitation (includes those instances that have been
previously treated with a plug due to paravalvular regurgitation).

4. Failing valve is unstable, rocking, or not structurally intact.

5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.

6. Increased risk of embolization of THV (e.g., surgical valve that is non-stented and
non-calcified).

7. Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index
procedure for implantation of the original valve.
We found this trial at
52
sites
Oklahoma City, Oklahoma 73120
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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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Boston, MA
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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Dallas, TX
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Gainesville, Florida 32611
(352) 392-3261
University of Florida Gainesville UF has a long history of established programs in international education,...
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Gainesville, FL
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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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Houston, TX
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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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Los Angeles, California 90095
310-825-4321
Principal Investigator: Richard Shemin, MD
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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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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Atlantis, FL
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Austin, Texas 78756
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Austin, TX
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Buffalo, New York 14215
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Buffalo, NY
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Charlotte, North Carolina 28204
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Charlotte, NC
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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Chicago, Illinois 60611
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, OH
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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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Dallas, Texas 75093
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Dallas, TX
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Evanston, IL
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3300 Gallows Road
Fairfax, Virginia 22042
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Fairfax, VA
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hartford, CT
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Kansas City, MO
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Lincoln, Nebraska 68526
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Lincoln, NE
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2500 Rocky Mountain Avenue
Loveland, Colorado 80538
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Loveland, CO
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Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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Madison, WI
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Memphis, Tennessee 38120
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Memphis, TN
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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Minneapolis, Minnesota 55455
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Minneapolis, MN
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Murray, UT
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102 Woodmont Boulevard
Nashville, Tennessee 37205
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Nashville, TN
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New Orleans, Louisiana 70121
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New Orleans, LA
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New York, NY
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New York, New York 10021
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Newark, New Jersey 07112
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Newark, NJ
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Norfolk, VA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Phoenix, Arizona 85006
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Phoenix, AZ
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Pittsburgh, PA
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Portland, Oregon 97220
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Portland, OR
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2800 Blue Ridge Road
Raleigh, North Carolina 27607
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Raleigh, NC
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Rochester, Minnesota 55905
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Rochester, MN
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Royal Oak, Michigan 48073
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Royal Oak, MI
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Sacramento, California 95816
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Sacramento, CA
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Saint Louis, Missouri 63110
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San Francisco, California 94115
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San Francisco, CA
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Springfield, Illinois 62701
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Springfield, IL
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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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Vancouver, British Columbia
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Wynnewood, Pennsylvania 19096
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