ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Study Overview
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Brief Summary
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The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Detailed Description
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Prospective, single arm, multicenter study

Official Title
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Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Conditions
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Aortic Valve Insufficiency, Aortic Valve Stenosis

Intervention / Treatment
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* Device: SAPIEN X4 THV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve<br>TAVR implant in subjects with a failing aortic surgical valve. | Device: SAPIEN X4 THV<br>* Implantation of the SAPIEN X4 valve<br>|
| Experimental: Transcatheter Aortic Valve Replacement (TAVR) - THV<br>TAVR implant in subjects with a failing aortic transcatheter heart valve (THV). | Device: SAPIEN X4 THV<br>* Implantation of the SAPIEN X4 valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-hierarchical composite of death and stroke | The number of patients that died or had a stroke | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) score | 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. | 30 days | 
| KCCQ score |  | 1 year | 
| New York Heart Association (NYHA) functional class | NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. | 30 days | 
| NYHA functional class |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter aortic valve replacement (TAVR), Transcatheter aortic valve implantation (TAVI), SAPIEN X4, Valve-in-valve