The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:9/27/2018
Start Date:March 9, 2011
End Date:May 30, 2017

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The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients

The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV
with the associated delivery system for inoperable patients with severe symptomatic native
aortic stenosis.

Cohort B was a 1:1 randomized, controlled study independently powered to compare
transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to
transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in
patients who could not undergo surgery (inoperable).

Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated
delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT
THV with the associated delivery system.

Inclusion Criteria

1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA
Functional Class II or greater.

2. The probability of death or serious, irreversible morbidity is greater than or equal
to 50%.

3. The heart team agreed (and verified in the case review process) that valve
implantation would likely benefit the patient.

4. The study patient or the study patient's legal representative was informed of the
nature of the study, agreed to its provisions and had provided written informed
consent as approved by the Institutional Review Board (IRB) of the respective clinical
site.

5. The study patient agreed to comply with all required post-procedure follow-up visits
including annual visits through 5 years and analysis close date visits, which was
conducted as a phone follow-up.

Exclusion Criteria

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

2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch
atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta.
(Transfemoral)

3. Currently participating in an investigational drug or another device study. Note:
Trials requiring extended follow-up for products that were investigational, but have
since become commercially available, are not considered investigational trials.

4. It is known that the patient is currently enrolled in the PARTNER I Trial or was
withdrawn from the PARTNER I Trial prior to endpoint analysis.

5. Active bacterial endocarditis within 6 months (180 days) of procedure.
We found this trial at
53
sites
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...
565
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Murray, UT
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
2578
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Boston, MA
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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...
2578
mi
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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...
1224
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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,...
2104
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Gainesville, FL
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
1527
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Iowa City, IA
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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...
13
mi
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Los Angeles, CA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
2320
mi
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Miami, FL
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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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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Austin, Texas 78756
1211
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Austin, TX
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
2301
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Baltimore, MD
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Charleston, North Carolina 29425
2284
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Charleston, 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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Cincinnati, Ohio 45219
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Cincinnati, OH
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Clearwater, Florida 33756
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Clearwater, FL
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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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Cleveland, OH
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Dallas, Texas 75093
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Dallas, TX
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Denver, Colorado 80262
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Denver, CO
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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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Greenville, NC
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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Kansas City, MO
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La Jolla, California 92037
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La Jolla, CA
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La Jolla, California 92037
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La Jolla, CA
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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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Little Rock, Arkansas 72211
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Little Rock, AR
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Louisville, Kentucky 40202
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Louisville, KY
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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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Manhasset, New York 11030
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Manhasset, NY
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Memphis, Tennessee 38120
1597
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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,...
2451
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Mineola, NY
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Minneapolis, Minnesota 55407
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New Orleans, Louisiana 70121
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New Orleans, LA
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New York, New York 10021
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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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Newark, New Jersey 07112
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Newark, NJ
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Oklahoma City, Oklahoma 73120
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19104
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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 95819
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Saint Louis, Missouri 63110
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San Antonio, TX
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Springfield, Illinois 62701
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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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110 Irving Street Northwest
Washington, District of Columbia 20010
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Washington,
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York, Pennsylvania 17315
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York, PA
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