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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05172973
Recruitment Status : Not yet recruiting
First Posted : December 29, 2021
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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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
Aortic Valve Insufficiency Aortic Valve Stenosis Device: SAPIEN X4 THV Not Applicable

Detailed Description:
Prospective, single arm, multicenter study
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Surgical Bioprosthetic Valves
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : February 2034

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcatheter Aortic Valve Replacement (TAVR) Device: SAPIEN X4 THV
Implantation of the SAPIEN X4 valve


Outcome Measures
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Primary Outcome Measures :
  1. Non-hierarchical composite of death and stroke [ Time Frame: 1 year ]
    The number of patients that died or had a stroke


Secondary Outcome Measures :
  1. Kansas City Cardiomyopathy Questionnaire (KCCQ) score [ Time Frame: 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.

  2. KCCQ score [ Time Frame: 1 year ]
  3. New York Heart Association (NYHA) functional class [ Time Frame: 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.

  4. NYHA functional class [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05172973


Contacts
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Contact: Edwards THV Clinical Affairs 949-250-2500 THV_CT.gov@Edwards.com

Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Tamim M. Nazif, MD Columbia University
Principal Investigator: Rahul P. Sharma, MBBS Stanford University
Principal Investigator: Pradeep Yadav, MD Piedmont Atlanta Hospital
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT05172973    
Other Study ID Numbers: 2021-05-AVIV
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Edwards Lifesciences:
Transcatheter aortic valve replacement (TAVR)
Transcatheter aortic valve implantation (TAVI)
SAPIEN X4
Valve-in-valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Insufficiency
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction