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

Completed · Not applicable

Conditions studied: Severe, Symptomatic, Calcific Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT02184442

Run by

Edwards Lifesciences

People needed

560

Starts

2011-03-09

Expected to finish

2017-05-30

Last updated by the study team

2018-09-25

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
• The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
• The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
• 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.
• 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.

You may not qualify if…

• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
• 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)
• 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.
• It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
• Active bacterial endocarditis within 6 months (180 days) of procedure.

Where it is running

• 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
• Arkansas Heart Hospital/Clinic — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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