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



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:9/22/2018
Start Date:March 2011
End Date:November 2024

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The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII A]

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN
XT transcatheter heart valve and delivery systems which are intended for use in patients with
symptomatic, calcific, severe aortic stenosis.

The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for
severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards
SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients
in the control arm will receive a surgical bioprosthetic heart valve via aortic valve
replacement surgery.

To assure that patients with an STS score ≥ 4% have been selected.

Inclusion Criteria

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

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

4. The study patient or the study patient's legal representative 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.

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

6. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if
randomized to control treatment.

Exclusion Criteria

1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended
treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥
twice normal in the presence of MB elevation and/or troponin level elevation (WHO
definition)].

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

3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation >3+).

4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).

5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is
performed within 30 days of the index procedure (unless part of planned strategy for
treatment of concomitant coronary artery disease). Implantation of a permanent
pacemaker or ICD (S3 Cohort only) is not excluded.

6. Heart team assessment of inoperability (including examining cardiac surgeon).
We found this trial at
56
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Memphis, Tennessee 38120
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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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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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...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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Sacramento, California 95814
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Seattle, Washington 98104
(206) 543-2100
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Austin, Texas 78756
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Camden, New Jersey 08103
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlottesville, Virginia 22903
(434) 924-0311
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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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303 East Superior Street
Chicago, Illinois 60611
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Clearwater, Florida 33756
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Dallas, Texas 75093
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Dallas, Texas 75230
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Denver, Colorado 80262
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Evanston, Illinois 60201
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Indianapolis, Indiana 46202
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La Jolla, California 92037
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La Jolla, California 92037
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Lincoln, Nebraska 68526
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Little Rock, Arkansas 72211
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Louisville, Kentucky 40245
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Madison, Wisconsin 53706
(608) 263-2400
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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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Minneapolis, Minnesota 55407
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New Orleans, Louisiana 70121
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New York, New York 10021
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630 W 168th St
New York, New York
212-305-2862
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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...
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
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Oklahoma City, Oklahoma 73120
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Philadelphia, Pennsylvania 19104
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Rochester, Minnesota 55905
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Royal Oak, Michigan 48073
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Sacramento, California 95819
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Saint Louis, Missouri 63110
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Springfield, Illinois 62701
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
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Vancouver, British Columbia
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
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York, Pennsylvania 17315
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