ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
- Conditions
- Aortic Stenosis, Severe
- Interventions
- Device: SAPIEN X4 THV
- Registration Number
- NCT05172960
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Detailed Description
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 915
- Severe, calcific AS
- Native aortic annulus size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid, bicuspid or non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position
- Severe aortic regurgitation (> 3+)
- Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis
- Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
- Left ventricular ejection fraction < 20%
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
- Increased risk of coronary artery obstruction after THV implantation
- Myocardial infarction within 30 days prior to the study procedure
- Hypertrophic cardiomyopathy with subvalvular obstruction
- Subjects with planned concomitant ablation for atrial fibrillation
- Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
- Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
- Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
- Endocarditis within 180 days prior to the study procedure
- Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
- Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
- Renal insufficiency and/or renal replacement therapy
- Leukopenia, anemia, thrombocytopenia
- Inability to tolerate or condition precluding treatment with antithrombotic therapy
- Hypercoagulable state or other condition that increases risk of thrombosis
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
- Subject refuses blood products
- BMI > 50 kg/m2
- Estimated life expectancy < 24 months
- Female who is pregnant or lactating
- Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Participating in another investigational drug or device study that has not reached its primary endpoint
- Subject considered to be part of a vulnerable population
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAVR - Main Cohort SAPIEN X4 THV Subjects will undergo transcatheter aortic valve replacement (TAVR) TAVR - Bicuspid Registry SAPIEN X4 THV Subjects with bicuspid aortic valve morphology will undergo TAVR
- Primary Outcome Measures
Name Time Method Non-hierarchical composite of death and stroke 1 year The number of patients that died or had a stroke
- Secondary Outcome Measures
Name Time Method New permanent pacemaker implantation 30 days The number of patients with this event
Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline 1 year The number of patients that met all of these criteria. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Paravalvular leak 30 days Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe
Trial Locations
- Locations (65)
Scripps Memorial Hospital La Jolla
🇺🇸La Jolla, California, United States
Kaiser Los Angeles
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
UC Davis Medical Center Sacramento
🇺🇸Sacramento, California, United States
Bay Area Structural Heart at Sutter Health
🇺🇸San Francisco, California, United States
Kaiser San Francisco Medical Center
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
UC Health Northern Colorado (Medical Center of the Rockies)
🇺🇸Loveland, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Naples Community Hospital Healthcare System
🇺🇸North Naples, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Emory University Atlanta
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center Chicago
🇺🇸Chicago, Illinois, United States
Alexian Brothers Hospital Network
🇺🇸Elk Grove Village, Illinois, United States
NorthShore University HealthSystem Research Institute Evanston
🇺🇸Evanston, Illinois, United States
Northwestern University Chicago
🇺🇸Evanston, Illinois, United States
Silver Cross Hospital
🇺🇸New Lenox, Illinois, United States
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC
🇺🇸Carmel, Indiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
Medstar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
CentraCare Heart and Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Washington University - Barnes-Jewish Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
St. Patrick Hospital
🇺🇸Missoula, Montana, United States
Dartmouth-Hitchcock Medical Center, Hanover
🇺🇸Lebanon, New Hampshire, United States
Atlantic Health System Morristown
🇺🇸Morristown, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
University at Buffalo - Kaleida Health
🇺🇸Buffalo, New York, United States
Cornell Medical Center
🇺🇸New York, New York, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
Montefiore Medical Center
🇺🇸New York, New York, United States
Carolinas Health System
🇺🇸Charlotte, North Carolina, United States
Novant Health and Heart Vascular Institute
🇺🇸Charlotte, North Carolina, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Oklahoma Cardiovascular Research Group Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Kaiser Portland
🇺🇸Clackamas, Oregon, United States
Providence Heart & Vascular Institute Portland
🇺🇸Portland, Oregon, United States
Pinnacle Health Harrisburg
🇺🇸Harrisburg, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist Le Bonheur Healthcare
🇺🇸Germantown, Tennessee, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Saint Thomas Health
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
HCA Houston Healthcare Medical Center
🇺🇸Houston, Texas, United States
University of Texas Memorial Hermann
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
University of Washington Seattle
🇺🇸Seattle, Washington, United States
St. Andrews War Memorial Hospital
🇦🇺Spring Hill, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Australia
St. Paul's Hospital System
🇨🇦Vancouver, British Columbia, Canada
Hamilton Health Services
🇨🇦Hamilton, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite Laval
🇨🇦Québec, Quebec, Canada
Christchurch Hospital
🇳🇿Christchurch, New Zealand