PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
a study on Aortic Stenosis
Summary
- Location
- at UCLA
- Dates
- study startedcompletion around
- Principal Investigator
- by Richard Shemin (ucla)
Description
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.
Official Title
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Details
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.
Keywords
Aortic Stenosis, SAPIEN 3, cardiovascular disease, heart disease, Surgical aortic valve replacement (SAVR), Transcatheter aortic valve replacement (TAVR), Aortic Valve Stenosis, Pathologic Constriction, SAVR, SAPIEN 3 THV
Eligibility
You can join 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 CAN'T join 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
- Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement
- Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation
- Patient refuses blood products
- Body mass index > 50 kg/m2
- Estimated life expectancy < 24 months
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- Immobility that would prevent completion of study procedures
- Patient is not a candidate for both arms of the study
- Currently participating in an investigational drug or another device study.
Locations
- University of California, Los Angeles/Ronald Reagan Medical Center
Los Angeles California 90095 United States - Kaiser Permanente San Francisco
San Francisco California 94115 United States - Cedars-Sinai Medical Center
Los Angeles California 90048 United States - Hoag Hospital
Newport Beach California 92663 United States - Mills/Peninsula Health Services
Burlingame California 94010 United States - Sutter Health Sacramento
Sacramento California 95816 United States - Stanford Hospital and Clinics
Palo Alto California 94305 United States
Lead Scientist at University of California Health
- Richard Shemin (ucla)
Dr. Richard J. Shemin holds the Robert and Kelly Day Chair in Cardiothoracic Surgery.
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Edwards Lifesciences
- ID
- NCT02675114
- Study Type
- Interventional
- Participants
- About 1000 people participating
- Last Updated