PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
- Conditions
- Symptomatic Severe Aortic Stenosis
- Interventions
- Device: TAVR Implantation of the THV Prosthesis
- Registration Number
- NCT03222141
- 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, severe aortic stenosis, and are in high risk.
- Detailed Description
This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 583
- Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.
- Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
- The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
- STS > 8
- Pre-existing mechanical or bioprosthetic valve in any position.
- Active bacterial endocarditis within 6 months (180 days) of procedure.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SAPIEN 3™ valve TAVR Implantation of the THV Prosthesis -
- Primary Outcome Measures
Name Time Method The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate 30 Days The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).
- Secondary Outcome Measures
Name Time Method Number of Participants With Major Vascular Complications 30 Days The rate of major vascular complications at 30 days post implantation
Number of Participants With Aortic Insufficiency at 30 Days 30 Days The proportion of patients with aortic insufficiency ≥ moderate at 30 days.
Trial Locations
- Locations (40)
Emory University
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Indiana University Health-Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Duke University
🇺🇸Durham, North Carolina, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Washington Hospital Center DC
🇺🇸Washington, District of Columbia, United States
Northwestern Hospital
🇺🇸Chicago, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
The University of Iowa
🇺🇸Iowa City, Iowa, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
MedStar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Washington University - Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Austin Heart, PLLC
🇺🇸Austin, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Providence St.Vincent Medical Center
🇺🇸Portland, Oregon, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
St. Paul's Hospital, Providence Health Care
🇨🇦Vancouver, British Columbia, Canada
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Cornell University
🇺🇸New York, New York, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States