The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:2/21/2019
Start Date:March 2016
End Date:March 2027
Contact:Justine Encabo, BS
Email:Justine-Encabo@edwards.com
Phone:949-250-3502

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A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve
in patients with severe, calcific aortic stenosis who are at low operative risk for standard
aortic valve replacement (AVR).

Prospective, randomized, controlled, multi-center trial. Patients having an operative
mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized
1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3
or aortic valve replacement with a commercially available surgical bioprosthetic valve.
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually
through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional
patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations
Registry (UPR) or the Alternative Access Registry.

Inclusion Criteria:

1. No age restriction.

2. Severe, calcific aortic stenosis.

3. Heart team agrees the patient has a risk of operative mortality and has an STS <4.

4. 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)/Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria:

1. Ilio-femoral vessel characteristics that would preclude safe placement of the
introducer sheath.

2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.

3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is
non-calcified.

4. Severe aortic regurgitation (>3+).

5. Severe mitral regurgitation (>3+).
We found this trial at
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Wynnewood, Pennsylvania 19096
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201 Dowman Dr
Atlanta, Georgia 30303
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
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Gainesville, Florida 32611
(352) 392-3261
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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Seattle, Washington 98104
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Albany, New York 12208
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5301 South Congress Avenue
Atlantis, Florida 33462
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593 Center Street
Auburn, Maine 04210
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Austin, Texas 78756
Principal Investigator: Frank Zidar, MD
Phone: 512-206-3600
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Birmingham, Alabama 35294
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Burlingame, California 94010
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28204
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Charlottesville, Virginia 22903
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Chermside, Queensland 4032
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303 East Superior Street
Chicago, Illinois 60611
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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Cincinnati, Ohio 45219
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Columbus, Ohio 43213
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2799 W Grand Blvd
Detroit, Michigan 48202
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3300 Gallows Road
Falls Church, Virginia 22042
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Hartford, Connecticut 06102
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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Lincoln, Nebraska 68526
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2500 Rocky Mountain Avenue
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Madison, Wisconsin 53792
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Memphis, Tennessee 38120
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Miami Beach, Florida 33140
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259 1st St
Mineola, New York 11501
(516) 663-0333
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Minneapolis, Minnesota 55455
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100 Madison Avenue
Morristown, New Jersey 07962
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102 Woodmont Boulevard
Nashville, Tennessee 37205
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Newark, New Jersey 07112
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Newport Beach, California 92658
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Oklahoma City, Oklahoma 73120
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601 E Rollins St
Orlando, Florida 32803
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3451 Walnut St
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320 E North Ave
Pittsburgh, Pennsylvania 15212
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1100 Allied Drive
Plano, Texas 75093
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