PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
- Conditions
- Aortic Stenosis
- Registration Number
- NCT02675114
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
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.
- Detailed Description
Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality \< 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.
A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/Quality of Life. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
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Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
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Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
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Evidence of an acute myocardial infarction ≤ 30 days before randomization
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Aortic valve is unicuspid, bicuspid, or non-calcified
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Severe aortic regurgitation (>3+)
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Severe mitral regurgitation (>3+) ≥ moderate stenosis
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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
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Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
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Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
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Hypertrophic cardiomyopathy with obstruction
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Ventricular dysfunction with LVEF < 30%
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Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
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Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
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Stroke or transient ischemic attack within 90 days of randomization
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Renal insufficiency and/or renal replacement therapy at the time of screening.
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Active bacterial endocarditis within 180 days of randomization
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Severe lung disease or currently on home oxygen
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Severe pulmonary hypertension
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History of cirrhosis or any active liver disease
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Significant frailty as determined by the Heart Team
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Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement
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Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation
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Patient refuses blood products
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Body mass index > 50 kg/m2
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Estimated life expectancy < 24 months
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Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
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Immobility that would prevent completion of study procedures
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Patient is not a candidate for both arms of the study
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Currently participating in an investigational drug or another device study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure) 1 year Number of patients that had any of these events
- Secondary Outcome Measures
Name Time Method Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points 30 days Number of patients that had any of these events
New Onset Atrial Fibrillation 30 days Number of patients with this event
Length of Index Hospitalization Discharge (expected average of 7 days) Number of days from index procedure to discharge
Death or Stroke 30 days Number of patients that died or had a stroke
All Stroke 30 days Number of patients that had a stroke
Trial Locations
- Locations (77)
University of Alabama
🇺🇸Birmingham, Alabama, United States
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
Scroll for more (67 remaining)University of Alabama🇺🇸Birmingham, Alabama, United States