ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Primary Purpose
Aortic Valve Insufficiency, Aortic Valve Stenosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SAPIEN X4 THV
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Insufficiency focused on measuring Transcatheter aortic valve replacement (TAVR), Transcatheter aortic valve implantation (TAVI), SAPIEN X4, Valve-in-valve
Eligibility Criteria
Inclusion Criteria:
- Failing surgical aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Bioprosthetic surgical 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve
Transcatheter Aortic Valve Replacement (TAVR) - THV
Arm Description
TAVR implant in subjects with a failing aortic surgical valve.
TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).
Outcomes
Primary Outcome Measures
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
Secondary Outcome Measures
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.
KCCQ score
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.
NYHA functional class
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05172973
Brief Title
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Official Title
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
February 2034 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. 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 risk with a failing aortic bioprosthetic valve.
Detailed Description
Prospective, single arm, multicenter study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Insufficiency, Aortic Valve Stenosis
Keywords
Transcatheter aortic valve replacement (TAVR), Transcatheter aortic valve implantation (TAVI), SAPIEN X4, Valve-in-valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve
Arm Type
Experimental
Arm Description
TAVR implant in subjects with a failing aortic surgical valve.
Arm Title
Transcatheter Aortic Valve Replacement (TAVR) - THV
Arm Type
Experimental
Arm Description
TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).
Intervention Type
Device
Intervention Name(s)
SAPIEN X4 THV
Intervention Description
Implantation of the SAPIEN X4 valve
Primary Outcome Measure Information:
Title
Non-hierarchical composite of death and stroke
Description
The number of patients that died or had a stroke
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Description
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.
Time Frame
30 days
Title
KCCQ score
Time Frame
1 year
Title
New York Heart Association (NYHA) functional class
Description
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.
Time Frame
30 days
Title
NYHA functional class
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edwards THV Clinical Affairs
Phone
949-250-2500
Email
THV_CT.gov@Edwards.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradeep Yadav, MD
Organizational Affiliation
Piedmont Atlanta Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Cubbedu, MD
Organizational Affiliation
Naples Community Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
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