This study is in progress, not accepting new patients
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
a study on Aortic Stenosis
Summary
- Location
- at UC Davis
- Dates
- study startedcompletion around
Description
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).
Official Title
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
Details
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
Keywords
Aortic Stenosis, Severe, Transcatheter aortic valve replacement (TAVR), Transcatheter aortic valve implantation (TAVI), SAPIEN X4, Aortic Valve Stenosis, SAPIEN X4 THV, TAVR - Bicuspid Registry
Eligibility
You can join if…
- 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.
You CAN'T join if...
- 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
Locations
- UC Davis Medical Center Sacramento
Sacramento California 95817 United States - Kaiser San Francisco Medical Center
San Francisco California 94115 United States - Scripps Memorial Hospital La Jolla
La Jolla California 92037 United States - Bay Area Structural Heart at Sutter Health
San Francisco California 94109 United States - Cedars-Sinai Medical Center
Los Angeles California 90048 United States - Hoag Memorial Hospital Presbyterian
Newport Beach California 92663 United States - Kaiser Los Angeles
Los Angeles California 90027 United States - Stanford University
Stanford California 94305 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Edwards Lifesciences
- ID
- NCT05172960
- Study Type
- Interventional
- Participants
- About 915 people participating
- Last Updated