The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
NCT ID: NCT02184442
Last Updated: 2018-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
560 participants
INTERVENTIONAL
2011-03-09
2017-05-30
Brief Summary
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THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
NCT00530894
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAVR - SAPIEN XT
TAVR (transaortic valve replacement) with SAPIEN XT
TAVR Implantation with SAPIEN XT
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
TAVR - SAPIEN
TAVR (transaortic valve replacement) with SAPIEN is the control arm
TAVR Implantation with SAPIEN
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Interventions
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TAVR Implantation with SAPIEN XT
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
TAVR Implantation with SAPIEN
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
ALL
No
Sponsors
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American College of Cardiology
OTHER
Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Martin B Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Arkansas Heart Hospital/Clinic
Little Rock, Arkansas, United States
Scripps Green Hospital
La Jolla, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mercy General Hospital
Sacramento, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Hospital
Denver, Colorado, United States
Washington Hospital Center (WHC)
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
University of Florida, Gainesville
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Indiana University Health-Methodist Hospital
Indianapolis, Indiana, United States
The University of Iowa
Iowa City, Iowa, United States
University of Louisville - Jewish Hospital
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Newark Beth Israel
Newark, New Jersey, United States
North Shore University Hospital, NY
Manhasset, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Cornell University
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Medical University of South Carolina Charleston
Charleston, North Carolina, United States
East Carolina Heart Institute at East Carolina University
Greenville, North Carolina, United States
The Christ Hospital, Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Austin Heart, PLLC
Austin, Texas, United States
The Heart Hospital Baylor Plano
Dallas, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio (UTHSCSA)
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Countries
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References
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Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.
Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.
Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.
Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.
Other Identifiers
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2010-12-PIIB
Identifier Type: -
Identifier Source: org_study_id
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