PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
- Conditions
- Symptomatic Severe Aortic Stenosis
- Interventions
- Device: TAVR
- Registration Number
- NCT03222128
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
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.
- Detailed Description
This study design consists of PIIS3i cohort.
The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access.
To ensure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1074
Not provided
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PIIS3i - SAPIEN 3 TAVR PIIS3i - SAPIEN 3 is Operable Group
- Primary Outcome Measures
Name Time Method Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate 1 year
- Secondary Outcome Measures
Name Time Method Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days 30 Days
Trial Locations
- Locations (51)
Northshore
🇺🇸Evanston, Illinois, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Northshore Long Island Jewish Health System
🇺🇸New Hyde Park, New York, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Washington University - Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Cornell University
🇺🇸New York, New York, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
East Carolina Heart Institute at East Carolina University
🇺🇸Greenville, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
The University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Maryland, Baltimore
🇺🇸Baltimore, Maryland, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
The Heart Hospital Baylor Plano
🇺🇸Dallas, Texas, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, 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 Lindner Center for Research & Education at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
University of Texas Health Science Center at San Antonio (UTHSCSA)
🇺🇸San Antonio, Texas, United States
York Hospital
🇺🇸York, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic-Saint Marys Hospital
🇺🇸Rochester, Minnesota, United States
Oklahoma Cardiovascular Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Providence Heart & Vascular Institute at Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
The Jewish Hospital Medical Center
🇺🇸Louisville, Kentucky, United States
Austin Heart, PLLC
🇺🇸Austin, Texas, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
St. Luke's Hospital - Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States