Clinical trial NCT06167213: ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
Official title: Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Mitral Valve Disease
Mitral Stenosis
Keywords: SAPIEN X4
Valve-in-Valve
Valve-in-Ring
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2023-12-12
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-hierarchical composite of death and stroke at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline
timeFrame: 30 days
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline
timeFrame: 1 year
measure: New York Heart Association (NYHA) functional class compared to baseline
timeFrame: 30 days
measure: New York Heart Association (NYHA) functional class compared to baseline
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Amar Krishnaswamy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: James McCabe, MD
role: PRINCIPAL_INVESTIGATOR
References: