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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
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Failing surgical aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
  2. Bioprosthetic surgical valve size suitable for SAPIEN X4 THV
  3. NYHA functional class ≥ II
  4. Heart Team agrees the subject is at high or greater surgical risk
  5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
  2. Failing valve has moderate or severe paravalvular regurgitation
  3. Failing valve is unstable, rocking, or not structurally intact
  4. 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
  5. Increased risk of THV embolization
  6. Surgical or transcatheter valve in the mitral position
  7. Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis
  8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
  9. Left ventricular ejection fraction < 20%
  10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  11. Increased risk of coronary artery obstruction after THV implantation
  12. Myocardial infarction within 30 days prior to the study procedure
  13. Hypertrophic cardiomyopathy with subvalvular obstruction
  14. Subjects with planned concomitant ablation for atrial fibrillation
  15. Clinically significant coronary artery disease requiring revascularization
  16. 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.
  17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
  18. Endocarditis within 180 days prior to the study procedure
  19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
  20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
  21. Renal insufficiency and/or renal replacement therapy
  22. Leukopenia, anemia, thrombocytopenia
  23. Inability to tolerate or condition precluding treatment with antithrombotic therapy
  24. Hypercoagulable state or other condition that increases risk of thrombosis
  25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
  26. Subject refuses blood products
  27. Body mass index > 50 kg/m2
  28. Estimated life expectancy < 24 months
  29. Female who is pregnant or lactating
  30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  31. 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

    First Posted
    December 14, 2021
    Last Updated
    June 16, 2023
    Sponsor
    Edwards Lifesciences
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    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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