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

Not Applicable

Active, not recruiting

• Conditions: Aortic Stenosis, Severe

• Registration Number: NCT05172960
• Lead Sponsor: Edwards Lifesciences

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).

Detailed Description

This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-29
• Study Start: 2022-06-20
• Primary Completion: 2025-07-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-14
• Study Completion: 2034-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 915

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Non-hierarchical composite of death and stroke	1 year	The number of patients that died or had a stroke

Secondary Outcome Measures

Name	Time	Method
New permanent pacemaker implantation	30 days	The number of patients with this event
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	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.
Paravalvular leak	30 days	Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe

Trial Locations

Locations (65)

Scripps Memorial Hospital La Jolla; 🇺🇸 La Jolla, California, United States

Kaiser Los Angeles; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

UC Davis Medical Center Sacramento; 🇺🇸 Sacramento, California, United States

Bay Area Structural Heart at Sutter Health; 🇺🇸 San Francisco, California, United States

Kaiser San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

UC Health Northern Colorado (Medical Center of the Rockies); 🇺🇸 Loveland, Colorado, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

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