PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

Running, not enrolling · Not applicable

Conditions studied: Aortic Stenosis

In brief

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

Key facts

Study ID

NCT02675114

Run by

Edwards Lifesciences

People needed

1000

Starts

2016-03-01

Expected to finish

2029-12-01

Last updated by the study team

2026-01-14

Who can join

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

You may qualify if…

• Severe, calcific aortic stenosis
• New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) <50%
• Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score < 4
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if…

• Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
• Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
• Evidence of an acute myocardial infarction ≤ 30 days before randomization
• Aortic valve is unicuspid, bicuspid, or non-calcified
• Severe aortic regurgitation (>3+)
• Severe mitral regurgitation (>3+) ≥ moderate stenosis
• Pre-existing mechanical or bioprosthetic valve in any position
• Complex coronary artery disease:
• Unprotected left main coronary artery
• Syntax score > 32
• Heart Team assessment that optimal revascularization cannot be performed
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
• Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
• Hypertrophic cardiomyopathy with obstruction
• Ventricular dysfunction with LVEF < 30%
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
• Stroke or transient ischemic attack within 90 days of randomization
• Renal insufficiency and/or renal replacement therapy at the time of screening.
• Active bacterial endocarditis within 180 days of randomization
• Severe lung disease or currently on home oxygen
• Severe pulmonary hypertension
• History of cirrhosis or any active liver disease
• Significant frailty as determined by the Heart Team

Where it is running

• Banner University Medical Center — Phoenix, Arizona, United States
• Mills/Peninsula Health Services — Burlingame, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, Los Angeles/Ronald Reagan Medical Center — Los Angeles, California, United States
• Hoag Hospital — Newport Beach, California, United States
• Stanford Hospital and Clinics — Palo Alto, California, United States
• Sutter Health Sacramento — Sacramento, California, United States
• Kaiser Permanente San Francisco — San Francisco, California, United States
• UC Health Northern Colorado/Medical Center of the Rockies — Loveland, Colorado, United States
• Hartford — Hartford, Connecticut, United States
• JFK Medical Center / Atlantic Clinical Research Collaborative — Atlantis, Florida, United States
• University of Florida, Gainesville — Gainesville, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• The Queen's Medical Center — Honolulu, Hawaii, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• NorthShore University HealthSystem Research Institute — Evanston, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Cardiovascular Research Institute of Kansas — Wichita, Kansas, United States
• UPR - Louisiana State University Health Science Center — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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