PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

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 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk.

Key facts

Study ID

NCT03222141

Run by

Edwards Lifesciences

People needed

583

Starts

2013-10-01

Expected to finish

2020-08-01

Last updated by the study team

2021-05-12

Who can join

Age: 19 and older. 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.
• STS > 8

You may not qualify if…

• Pre-existing mechanical or bioprosthetic valve in any position.
• Active bacterial endocarditis within 6 months (180 days) of procedure.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.

Where it is running

• 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 DC — Washington D.C., District of Columbia, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• Emory University — 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
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States
• Nebraska Heart Institute — Lincoln, Nebraska, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, 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
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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