The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - Nested Registry 3/Valve-in-Valve



Status:Active, not recruiting
Conditions:Cardiology, Cardiology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:19 - Any
Updated:9/27/2018
Start Date:June 11, 2012
End Date:December 16, 2020

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PARTNER II Nested Registry 3 (NR3)/Valve-in-Valve (ViV) is a Prospective, Single-arm, Multicenter Clinical Trial That Will Establish the Safety and Efficacy of SAPIEN XT THV in Greater-risk Patients With a Failing Aortic Bioprosthetic Valve.

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients
with a failing surgical aortic bioprosthetic valve.

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

Inclusion Criteria:

1. 1.Patient has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an
initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2. Qualifying
echo must be within 60 days of the date of the procedure.

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

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. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.

6. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic
position.

Exclusion Criteria:

1. Bioprosthetic valve labeled external diameter < 21mm.

2. Surgical or transcatheter valve in another position on the same side of the heart
(mitral and tricuspid rings are not an exclusion).

3. Infectious endocarditis within 6 months.

4. Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
We found this trial at
47
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Denver, Colorado 80262
820
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Denver, CO
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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
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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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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
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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
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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...
961
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Seattle, WA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
1932
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Ann Arbor, MI
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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...
1922
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Atlanta, GA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
2184
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Charleston, SC
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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...
2205
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Charlottesville, VA
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Chicago, Illinois 60611
1730
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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...
1879
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Cincinnati, OH
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Clearwater, Florida 33756
2117
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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...
2033
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Cleveland, OH
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Dallas, Texas 75093
1224
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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...
1965
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Detroit, MI
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1728
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Evanston, IL
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2290
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Greenville, NC
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1357
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Houston, TX
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1341
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Kansas City, MO
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La Jolla, California 92037
95
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La Jolla, CA
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La Jolla, California 92037
95
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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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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...
1654
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Madison, WI
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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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Minneapolis, MN
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New Orleans, Louisiana 70121
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New York, New York 10021
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New York, NY
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
2423
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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...
2336
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Norfolk, VA
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Oklahoma City, Oklahoma 73120
1162
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Oklahoma City, OK
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
2373
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Philadelphia, PA
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9205 Southwest Barnes Road
Portland, Oregon 97225
829
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Portland, OR
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Rochester, Minnesota 55905
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Rochester, MN
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Royal Oak, Michigan 48073
1960
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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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Salt Lake City, Utah 84157
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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...
328
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Stanford, CA
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Vancouver, British Columbia
1082
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Vancouver,
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110 Irving Street Northwest
Washington, District of Columbia 20010
2282
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Washington,
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