Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease
Conditions
Keywords
SAPIEN X4, Valve-in-Valve, Valve-in-Ring
Brief summary
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.
Detailed description
This is a prospective, single arm, multicenter, pivotal study.
Interventions
DEVICESAPIEN X4 THV
Implantation of the SAPIEN X4 valve
Sponsors
Edwards Lifesciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency 2. Bioprosthetic surgical valve or native mitral annulus 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. Interatrial septum or left atrium not suitable for transcatheter transseptal access 3. Failing valve has mild or greater paravalvular regurgitation 4. Failing valve is unstable, rocking, or not structurally intact 5. Annuloplasty ring dehiscence 6. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 10 mmHg at the end of the index procedure for implantation of the original valve 7. Annuloplasty ring type not favorable for THV implantation 8. Increased risk of THV embolization 9. Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction 10. Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant 11. Severe right ventricle (RV) dysfunction 12. Severe regurgitation or stenosis of any other valve 13. Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months 14. Left ventricular ejection fraction \< 20% 15. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 16. Myocardial infarction within 30 days prior to the study procedure 17. Hypertrophic cardiomyopathy with subvalvular obstruction 18. Subjects with planned concomitant ablation for atrial fibrillation 19. Clinically significant coronary artery disease requiring revascularization 20. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion. 21. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure 22. Endocarditis within 180 days prior to the study procedure 23. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure 24. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure 25. Renal insufficiency and/or renal replacement therapy 26. Leukopenia, anemia, thrombocytopenia 27. Inability to tolerate or condition precluding treatment with antithrombotic therapy 28. Hypercoagulable state or other condition that increases risk of thrombosis 29. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication 30. Subject refuses blood products 31. Body mass index \> 50 kg/m2 32. Estimated life expectancy \< 24 months 33. Female who is pregnant or lactating 34. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 35. Participating in another investigational drug or device study that has not reached its primary endpoint 36. Subject considered to be part of a vulnerable population
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-hierarchical composite of death and stroke at 1 year | 1 year | The number of patients that died or had a stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline | 30 days | 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. |
| New York Heart Association (NYHA) functional class compared to baseline | 30 days | NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. |
Contacts
Primary ContactEdwards THV Clinical Affairs
Outcome results
None listed