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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05172960
Recruitment Status : Active, not recruiting
First Posted : December 29, 2021
Last Update Posted : December 12, 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 with symptomatic, severe, calcific aortic stenosis (AS).

Condition or disease Intervention/treatment Phase
Aortic Stenosis, Severe Device: SAPIEN X4 THV Not Applicable

Detailed Description:
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 915 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
Actual Study Start Date : June 20, 2022
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : December 2034

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAVR - Main Cohort
Subjects will undergo transcatheter aortic valve replacement (TAVR)
 Device: SAPIEN X4 THV
Implantation of the SAPIEN X4 valve
Experimental: TAVR - Bicuspid Registry
Subjects with bicuspid aortic valve morphology will undergo 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. Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline [ Time Frame: 1 year ]
    The number of patients that met all of these criteria. 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. Paravalvular leak [ Time Frame: 30 days ]
    Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe

  3. New permanent pacemaker implantation [ Time Frame: 30 days ]
    The number of patients with this event


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. Severe, calcific AS
  2. Native aortic annulus size suitable for SAPIEN X4 THV
  3. NYHA functional class ≥ II
  4. 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. Aortic valve is unicuspid, bicuspid or non-calcified
  3. Pre-existing mechanical or bioprosthetic valve in any position
  4. Severe aortic regurgitation (> 3+)
  5. Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis
  6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
  7. Left ventricular ejection fraction < 20%
  8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
  10. Increased risk of coronary artery obstruction after THV implantation
  11. Myocardial infarction within 30 days prior to the study procedure
  12. Hypertrophic cardiomyopathy with subvalvular obstruction
  13. Subjects with planned concomitant ablation for atrial fibrillation
  14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
  15. Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
  16. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
  17. Endocarditis within 180 days prior to the study procedure
  18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
  19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
  20. Renal insufficiency and/or renal replacement therapy
  21. Leukopenia, anemia, thrombocytopenia
  22. Inability to tolerate or condition precluding treatment with antithrombotic therapy
  23. Hypercoagulable state or other condition that increases risk of thrombosis
  24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
  25. Subject refuses blood products
  26. BMI > 50 kg/m2
  27. Estimated life expectancy < 24 months
  28. Female who is pregnant or lactating
  29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  30. 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): NCT05172960


Locations
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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
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT05172960    
Other Study ID Numbers: 2021-05
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 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
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction