PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

Completed · Not applicable

Conditions studied: Symptomatic Severe Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT01314313

Run by

Edwards Lifesciences

People needed

2032

Starts

2011-03-01

Expected to finish

2024-01-17

Last updated by the study team

2024-03-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
• The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
• 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.
• 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.
• Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.

You may not qualify if…

• 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)].
• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
• Preexisting mechanical or bioprosthetic valve in any position (except NR3).
• 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.
• Heart team assessment of inoperability (including examining cardiac surgeon).

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
• UC Davis Medical Center — Sacramento, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Hospital — Denver, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• University of Miami Hospital Miller School of Medicine — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Northshore — Evanston, 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
• The Jewish Hospital Medical Center — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland, Baltimore — 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
• Arkansas Heart Hospital/Clinic — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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