Aortic Stenosis: Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

What is the Purpose of this Study?

The purpose of this study is to determine whether an investigational device called the Sapien X4 Transcatheter Heart Valve system is beneficial for patients with symptomatic, severe, calcific aortic stenosis. Aortic stenosis is a condition in which the opening of the heart valve becomes smaller, making it more difficult for the heart to pump blood. In this study, participants will have their valve replaced by the Sapien X4 Transcatheter Heart Valve system, which includes an artificial heart valve and accessories used to implant the valve. Each valve consists of a stent (metal mesh tube) made of a metal frame with knitted fabric covering some of the frame. The SAPIEN X4 delivery system consists of a catheter (a long, thin, bendable tube that is placed in a blood vessel) that is inserted through an incision made in the groin and moved through blood vessels to the heart.

Eligibility

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.

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
31. Subject considered to be part of a vulnerable population

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Safety and Effectiveness of Balloon-Expanding Bioprosthetic Sapien X4 Trascather Heart Valve -ALLIANCE Study

Study Details

Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00002097

ClinicalTrials.gov ID

NCT05172960

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org