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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Bay Area Structural Heart at Sutter Health
  San Francisco, California, United States Recruiting
• Stanford University Medical Center
  Stanford, California, United States Recruiting
• UC Health Medical Center of the Rockies
  Loveland, Colorado, United States Recruiting
• Naples Community Hospital Healthcare System
  Naples, Florida, United States Recruiting
• Emory University Atlanta
  Atlanta, Georgia, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Robert Cubbedu, MD — Naples Community Hospital
• Study coordinator: Edwards THV Clinical Affairs
• Email: THV_CT.gov@Edwards.com
• Phone: 949-250-2500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Korea VHD Echo Study: Real-World Practice of Aortic, Mitral, and Tricuspid Valves

  This study looks at how valvular heart disease is managed in Korea by reviewing echocardiograms and medical records from multiple centers to see patterns in disease progression and treatment.

  Recruiting at 2 sites Yonsei University · Seoul, Seoul and 1 other locations · NCT07068633

• Investigating multiple and mixed heart valve diseases

  This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06235385

• Improving TAVI outcomes with point-of-care testing for Von Willebrand Factor

  This study is testing whether quick testing for Von Willebrand Factor during TAVI procedures can help improve outcomes and reduce complications for patients with aortic stenosis.

  Recruiting at 4 sites University Hospital, Lille · Clermont-Ferrand and 8 other locations · NCT03728049

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.