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

Not Applicable

Active, not recruiting

Conditions: Aortic Stenosis

Interventions: Device: SAPIEN 3 THV
Procedure: SAVR

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

Inclusion Criteria

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.

Exclusion Criteria

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:
1. Unprotected left main coronary artery
2. Syntax score > 32
3. 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcatheter aortic valve replacement (TAVR)	SAPIEN 3 THV	-
Surgical aortic valve replacement (SAVR)	SAVR	-

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
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
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
All Stroke	30 days	Number of patients that had a stroke

Trial Locations

Locations (77): Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Mount Carmel Health System
🇺🇸
Columbus, Ohio, United States
The University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
University of Minnesota Medical Center
🇺🇸
Minneapolis, Minnesota, United States
The Christ Hospital, Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Banner University Medical Center
🇺🇸
Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
University of Alabama
🇺🇸
Birmingham, Alabama, United States
Mills/Peninsula Health Services
🇺🇸
Burlingame, California, United States
Central Maine Medical Center
🇺🇸
Auburn, Maine, United States
University of Florida, Gainesville
🇺🇸
Gainesville, Florida, United States
Hartford
🇺🇸
Hartford, Connecticut, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Saint Thomas Health Services
🇺🇸
Nashville, Tennessee, United States
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, United States
UPR-Oklahoma Heart Institute
🇺🇸
Tulsa, Oklahoma, United States
Oklahoma Cardiovascular Research Group
🇺🇸
Oklahoma City, Oklahoma, United States
Providence Heart & Vascular Institute
🇺🇸
Portland, Oregon, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Intermountain Medical Center
🇺🇸
Salt Lake City, Utah, United States
The Heart Hosptial Baylor Plano
🇺🇸
Plano, Texas, United States
Lankenau Medical Center
🇺🇸
Wynnewood, Pennsylvania, United States
Medical City Dallas Hospital
🇺🇸
Dallas, Texas, United States
Sentara Cardiovascular Research Institute
🇺🇸
Norfolk, Virginia, United States
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Auckland City Hospital
🇳🇿
Grafton, Auckland, New Zealand
University of Washington
🇺🇸
Seattle, Washington, United States
Hoag Hospital
🇺🇸
Newport Beach, California, United States
University of California, Los Angeles/Ronald Reagan Medical Center
🇺🇸
Los Angeles, California, United States
Stanford Hospital and Clinics
🇺🇸
Palo Alto, California, United States
Kaiser Permanente San Francisco
🇺🇸
San Francisco, California, United States
JFK Medical Center / Atlantic Clinical Research Collaborative
🇺🇸
Atlantis, Florida, United States
UC Health Northern Colorado/Medical Center of the Rockies
🇺🇸
Loveland, Colorado, United States
Mount Sinai Medical Center
🇺🇸
Miami Beach, Florida, United States
NorthShore University HealthSystem Research Institute
🇺🇸
Evanston, Illinois, United States
The Queen's Medical Center
🇺🇸
Honolulu, Hawaii, United States
Prairie Education and Research Cooperative
🇺🇸
Springfield, Illinois, United States
Cardiovascular Research Institute of Kansas
🇺🇸
Wichita, Kansas, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Nebraska Heart Institute
🇺🇸
Lincoln, Nebraska, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Barnes-Jewish Hospital / Washington University
🇺🇸
Saint Louis, Missouri, United States
Morristown Medical Center / Atlantic Health System Hospital
🇺🇸
Morristown, New Jersey, United States
Winthrop-University Hospital
🇺🇸
Mineola, New York, United States
University of Buffalo
🇺🇸
Buffalo, New York, United States
NYU Medical Center
🇺🇸
New York, New York, United States
Newark Beth Israel
🇺🇸
Newark, New Jersey, United States
Albany
🇺🇸
Albany, New York, United States
Columbia University Medical Center/ New York Presbyterian Hospital
🇺🇸
New York, New York, United States
Cornell University
🇺🇸
New York, New York, United States
Rex Hospital / NC Heart and Vascular Research
🇺🇸
Raleigh, North Carolina, United States
Carolina's Health System
🇺🇸
Charlotte, North Carolina, United States
UPR - Novant Health Heart and Vascular Institution
🇺🇸
Charlotte, North Carolina, United States
Fairfax INOVA
🇺🇸
Falls Church, Virginia, United States
University of Wisconsin
🇺🇸
Madison, Wisconsin, United States
Saint Paul's Hospital
🇨🇦
Vancouver, Canada
Sendai Kousei Hospital
🇯🇵
Sendai, Miyagi, Japan
Osaka University
🇯🇵
Suita, Osaka, Japan
Flinders Medical Centre
🇦🇺
Bedford Park, South Australia, Australia
Kokura Memorial Hospital
🇯🇵
Kitakyushu, Fukuoka, Japan
Teikyo University
🇯🇵
Itabashi, Tokyo, Japan
Florida Hospital
🇺🇸
Orlando, Florida, United States
Sutter Health Sacramento
🇺🇸
Sacramento, California, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City Mid America
🇺🇸
Kansas City, Missouri, United States
UPR - Louisiana State University Health Science Center
🇺🇸
New Orleans, Louisiana, United States
Austin Heart
🇺🇸
Austin, Texas, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Keio University
🇯🇵
Shinjuku, Tokyo, Japan
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
York Hospital
🇺🇸
York, Pennsylvania, United States