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Evaluating the SAPIEN X4 Heart Valve for Patients with Failing Aortic Bioprosthetic Valves

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Not applicable Interventional Edwards Lifesciences · NCT05172973

This study is testing a new heart valve to see if it can help people with failing aortic bioprosthetic valves feel better and stay healthy.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment200 (estimated)
SexAll
SponsorEdwards Lifesciences Industry-sponsored
Locations35 sites (Newport Beach, California and 34 other locations)
Trial IDNCT05172973 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve in patients who have a failing aortic bioprosthetic valve. It is a prospective, single-arm, multicenter study involving participants at high or greater surgical risk due to conditions such as aortic valve insufficiency or stenosis. The study will monitor outcomes related to valve performance and patient health following the valve replacement procedure.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with a failing aortic bioprosthetic valve who demonstrate moderate stenosis or insufficiency and are considered at high surgical risk.

Not a fit: Patients with anatomical issues that prevent safe valve placement or those with severe paravalvular regurgitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with failing aortic bioprosthetic valves, potentially improving their quality of life and health outcomes.

How similar studies have performed: Other studies have shown promising results with transcatheter heart valve replacements, indicating that this approach is both viable and beneficial for similar patient populations.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
2. Bioprosthetic 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
32. Subject considered to be part of a vulnerable population

Where this trial is running

Newport Beach, California and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic Valve InsufficiencyAortic Valve StenosisTranscatheter aortic valve replacementTranscatheter aortic valve implantationSAPIEN X4Valve-in-valve
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.