ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Launched by EDWARDS LIFESCIENCES · Dec 14, 2021

Keywords

ClinConnect Summary

The ALLIANCE AVIV clinical trial is studying the safety and effectiveness of a new heart valve called the SAPIEN X4 Transcatheter Heart Valve (THV) for patients who have a failing aortic bioprosthetic valve. This trial is specifically for people who are at high risk for surgery and are experiencing significant issues with their current valve, such as narrowing (stenosis) or leakage (insufficiency). If you're an adult with these heart valve problems and your doctor believes you're a good candidate, you may be eligible to participate.

Participants in this trial can expect to receive the new heart valve through a less invasive procedure, meaning they won't need major surgery. The study is currently recruiting participants, and to join, you would need to provide consent and meet certain health criteria, such as having a failing valve that needs replacement and being in a functional class where your heart condition is affecting your daily activities. It’s important to know that there are specific conditions that might exclude you from participation, such as severe heart issues or recent heart-related complications. This trial could help improve treatment options for patients with similar heart conditions in the future.

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Eligibility 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