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Trial record 1 of 1 for:    NCT06167213
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ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral

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ClinicalTrials.gov Identifier: NCT06167213
Recruitment Status : Not yet recruiting
First Posted : December 12, 2023
Last Update Posted : December 12, 2023
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
This study will 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 mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Mitral Valve Disease Mitral Stenosis Device: SAPIEN X4 THV Not Applicable

Detailed Description:
This is a prospective, single arm, multicenter, pivotal study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
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 - Mitral
Estimated Study Start Date : September 2024
Estimated Primary Completion Date : March 2029
Estimated Study Completion Date : March 2038
Arms and Interventions
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Arm Intervention/treatment
Experimental: TMVR in failing mitral surgical bioprosthetic valve
Transcatheter Mitral Valve Replacement (TMVR) in subjects with a failing mitral surgical bioprosthetic valve.
 Device: SAPIEN X4 THV
Implantation of the SAPIEN X4 valve
Experimental: TMVR in failing native mitral valve with an annuloplasty ring
Transcatheter Mitral Valve Replacement (TMVR) in subjects with a failing native mitral valve with an annuloplasty ring.
 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 at 1 year [ Time Frame: 1 year ]
    The number of patients that died or had a stroke


Secondary Outcome Measures :
  1. Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline [ 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. Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline [ Time Frame: 1 year ]

    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.


  3. New York Heart Association (NYHA) functional class compared to baseline [ 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. New York Heart Association (NYHA) functional class compared to baseline [ Time Frame: 1 year ]
    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.


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 mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
  2. Bioprosthetic surgical valve or native mitral annulus 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. Interatrial septum or left atrium not suitable for transcatheter transseptal access
  3. Failing valve has mild or greater paravalvular regurgitation
  4. Failing valve is unstable, rocking, or not structurally intact
  5. Annuloplasty ring dehiscence
  6. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 10 mmHg at the end of the index procedure for implantation of the original valve
  7. Annuloplasty ring type not favorable for THV implantation
  8. Increased risk of THV embolization
  9. Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction
  10. Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant
  11. Severe right ventricle (RV) dysfunction
  12. Severe regurgitation or stenosis of any other valve
  13. Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months
  14. Left ventricular ejection fraction < 20%
  15. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  16. Myocardial infarction within 30 days prior to the study procedure
  17. Hypertrophic cardiomyopathy with subvalvular obstruction
  18. Subjects with planned concomitant ablation for atrial fibrillation
  19. Clinically significant coronary artery disease requiring revascularization
  20. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
  21. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
  22. Endocarditis within 180 days prior to the study procedure
  23. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
  24. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
  25. Renal insufficiency and/or renal replacement therapy
  26. Leukopenia, anemia, thrombocytopenia
  27. Inability to tolerate or condition precluding treatment with antithrombotic therapy
  28. Hypercoagulable state or other condition that increases risk of thrombosis
  29. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
  30. Subject refuses blood products
  31. Body mass index > 50 kg/m2
  32. Estimated life expectancy < 24 months
  33. Female who is pregnant or lactating
  34. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  35. Participating in another investigational drug or device study that has not reached its primary endpoint
  36. Subject considered to be part of a vulnerable population
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): NCT06167213


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: Amar Krishnaswamy, MD The Cleveland Clinic
Principal Investigator: James McCabe, MD University of Washington
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT06167213    
Other Study ID Numbers: 2021-05-Mitral
First Posted: December 12, 2023    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023
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:
SAPIEN X4
Valve-in-Valve
Valve-in-Ring
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Mitral Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases