ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Surgical Bioprosthetic Valves
Study Details
Study Description
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 who are at high or greater surgical risk with a failing aortic surgical bioprosthetic valve.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Prospective, single arm, multicenter study
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transcatheter Aortic Valve Replacement (TAVR)
|
Device: SAPIEN X4 THV
Implantation of the SAPIEN X4 valve
|
Outcome Measures
Primary Outcome Measures
- Non-hierarchical composite of death and stroke [1 year]
The number of patients that died or had a stroke
Secondary Outcome Measures
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score [30 days]
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.
- KCCQ score [1 year]
- New York Heart Association (NYHA) functional class [30 days]
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.
- NYHA functional class [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Failing surgical aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
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Bioprosthetic surgical valve size suitable for SAPIEN X4 THV
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NYHA functional class ≥ II
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Heart Team agrees the subject is at high or greater surgical risk
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The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
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Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
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Failing valve has moderate or severe paravalvular regurgitation
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Failing valve is unstable, rocking, or not structurally intact
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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
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Increased risk of THV embolization
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Surgical or transcatheter valve in the mitral position
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Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis
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Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
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Left ventricular ejection fraction < 20%
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Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
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Increased risk of coronary artery obstruction after THV implantation
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Myocardial infarction within 30 days prior to the study procedure
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Hypertrophic cardiomyopathy with subvalvular obstruction
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Subjects with planned concomitant ablation for atrial fibrillation
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Clinically significant coronary artery disease requiring revascularization
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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.
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Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
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Endocarditis within 180 days prior to the study procedure
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Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
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Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
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Renal insufficiency and/or renal replacement therapy
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Leukopenia, anemia, thrombocytopenia
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Inability to tolerate or condition precluding treatment with antithrombotic therapy
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Hypercoagulable state or other condition that increases risk of thrombosis
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Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
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Subject refuses blood products
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Body mass index > 50 kg/m2
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Estimated life expectancy < 24 months
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Female who is pregnant or lactating
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Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
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Participating in another investigational drug or device study that has not reached its primary endpoint
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Edwards Lifesciences
Investigators
- Principal Investigator: Tamim M. Nazif, MD, Columbia University
- Principal Investigator: Rahul P. Sharma, MBBS, Stanford University
- Principal Investigator: Pradeep Yadav, MD, Piedmont Atlanta Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-05-AVIV