Heart & Vascular Clinical Trials
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Surgical Bioprosthetic Valves
Learn moreWhat is the purpose of this study?
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
Eligibility
- Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Bioprosthetic valve size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
- Heart Team agrees the subject is at high or greater surgical risk
- 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
- Failing valve has moderate or severe paravalvular regurgitation
- Failing valve is unstable, rocking, or not structurally intact
- Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
- Increased risk of THV embolization
- Surgical or transcatheter valve in the mitral position
- 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
- 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
- Clinically significant coronary artery disease requiring revascularization
- Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
- Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
- 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
- Body mass index > 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
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
- Disease Type/ConditionAortic Valve Insufficiency, Aortic Valve Stenosis
- Principal InvestigatorMahmoud Eslami, MD
- Co-InvestigatorsAnthony Caffarelli, MD, Gennie Yee, MD, Jorge Castellanos, MD, Cheng-Han Chen, MD, Kevin Kheder, MD, Asad Shah, MD
- Age GroupChild, Adult, Older Adult
- PhaseN/A
- ClinicalTrials.gov IDNCT05172973
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Jeffrey M. Carlton Heart & Vascular Institute
Hoag’s Jeffrey M. Carlton Heart & Vascular Institute provides advanced, coordinated care for complex heart and vascular conditions, bringing together nationally recognized cardiologists, cardiac surgeons, electrophysiologists, heart failure specialists, and vascular experts. Patients have access to comprehensive evaluation, leading cardiovascular programs, advanced treatment options, and clinical trials designed to help identify the right path forward.
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