PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
- Conditions
- Cardiomyopathy, HypertrophicAortic Stenosis
- Interventions
- Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Registration Number
- NCT03225001
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Detailed Description
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
- 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 was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
- Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.
- Bioprosthetic valve labeled external diameter < 21mm.
- Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
- Infectious endocarditis within 6 months.
- Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Failing surgical valve Edwards SAPIEN XT transcatheter valve, Model 9300TFX Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
- Primary Outcome Measures
Name Time Method Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) 30-day The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
- Secondary Outcome Measures
Name Time Method Number of Participants With Mortality From Any Cause 30 Days Cardiovascular cause is also included
Trial Locations
- Locations (47)
East Carolina Heart Institute at East Carolina University
🇺🇸Greenville, North Carolina, United States
The Heart Hospital Baylor Plano
🇺🇸Dallas, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Northwestern Hospital
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Miami
🇺🇸Miami, Florida, United States
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
St. Paul's Hospital, Providence Health Care
🇨🇦Vancouver, British Columbia, Canada
Cornell University
🇺🇸New York, New York, United States
Providence St.Vincent Medical Center
🇺🇸Portland, Oregon, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
Mayo Clinic-Saint Marys Hospital
🇺🇸Rochester, Minnesota, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Washington Hospital Center (WHC)
🇺🇸Washington, District of Columbia, United States
NorthShore University HealthSystem Research Institute
🇺🇸Evanston, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
The University of Iowa
🇺🇸Iowa City, Iowa, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Washington University - Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Winthrop-University Hospital
🇺🇸Mineola, New York, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Columbia University Medical Center/ New York Presbyterian Hospital
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
University of Louisville Jewish Hospital
🇺🇸Louisville, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Saint Luke's Hospital of Kansas City Mid America
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States