PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate

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, and severe aortic stenosis, and those with intermediate risk.

Key facts

Study ID

NCT03222128

Run by

Edwards Lifesciences

People needed

1074

Starts

2014-02-17

Expected to finish

2024-10-09

Last updated by the study team

2025-01-03

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.

You may not qualify if…

• Heart team assessment of inoperability (including examining cardiac surgeon).
• Complex coronary artery disease
• Unprotected left main coronary artery
• Syntax score > 32 (in the absence of prior revascularization)
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.
• Need for emergency surgery for any reason.

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 — Washington D.C., District of Columbia, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• University of Florida — Gainesville, 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
• St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC — 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
• 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-Saint Marys Hospital — Rochester, Minnesota, United States
• St. Luke's Hospital - Mid America Heart Institute — Kansas City, Missouri, United States
• Scripps Green Hospital — La Jolla, California, United States

Full record on ClinicalTrials.gov

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