SAPIEN X4 Transcatheter Heart Valve safety and effectiveness in severe aortic stenosis

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 is a prospective, multicenter study evaluating a single treatment approach using the SAPIEN X4/X4S transcatheter heart valve. It enrolls patients with severe calcific aortic stenosis to assess safety and effectiveness of THV implantation. A separate registry will enroll patients with bicuspid aortic valve morphology. Key eligibility includes suitable annulus size, NYHA class II or higher, and informed consent, while several anatomical and clinical factors may exclude participation. The study is sponsored by Edwards Lifesciences with sites in California.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• UC Davis Medical Center Sacramento
  Sacramento, California, United States Recruiting
• Bay Area Structural Heart at Sutter Health
  San Francisco, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Hartford Hospital
  Hartford, Connecticut, United States Recruiting
• Alexian Brothers Hospital Network
  Elk Grove Village, Illinois, United States Recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Tamim M. Nazif, MD — Columbia University
• 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.

• Imaging data collection for patients undergoing Transcatheter Aortic Valve Implantation

  This study is collecting imaging data from patients with severe aortic stenosis who are getting a new heart valve to see if these scans can help predict how well the valve will work in the future.

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• Using lung ultrasound to improve outcomes in cardiac surgery patients

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  Recruiting Saint Petersburg State University, Russia · Saint Petersburg, Sankt-Peterburg · NCT06377449

• Exercise testing using cardiac MRI for patients with severe aortic stenosis

  This study is testing how patients with severe aortic stenosis respond to exercise using advanced heart imaging to help doctors make better treatment choices before they get a heart valve replacement.

  Recruiting University of Göttingen · Göttingen · NCT06129799

• Aortic valve replacement using SAPIEN 3 for failing bioprosthetic valves

  This study is testing if the SAPIEN 3 heart valves can safely help patients with failing bioprosthetic aortic valves feel better.

  Recruiting at 30 sites Edwards Lifesciences · Phoenix, Arizona and 50 other locations · NCT03003299

• Registry of Transcatheter Aortic Valve Treatments at a Italian Center

  This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT07596394

• CT-FFR-guided revascularization for people with severe aortic stenosis

  This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

  Recruiting Yan'an Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07469371

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.