Status:
NOT_YET_RECRUITING
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Regurgitation
Mitral Valve Disease
Eligibility:
All Genders
Phase:
NA
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 biop...
Detailed Description
This is a prospective, single arm, multicenter, pivotal study.
Eligibility Criteria
Inclusion
- Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
- Heart Team agrees the subject is at high or greater surgical risk
- The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Exclusion
- Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- Interatrial septum or left atrium not suitable for transcatheter transseptal access
- Failing valve has mild or greater paravalvular regurgitation
- Failing valve is unstable, rocking, or not structurally intact
- Annuloplasty ring dehiscence
- 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
- Annuloplasty ring type not favorable for THV implantation
- Increased risk of THV embolization
- Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction
- Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant
- Severe right ventricle (RV) dysfunction
- Severe regurgitation or stenosis of any other valve
- Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months
- Left ventricular ejection fraction \< 20%
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- Myocardial infarction within 30 days prior to the study procedure
- Hypertrophic cardiomyopathy with subvalvular obstruction
- Subjects with planned concomitant ablation for atrial fibrillation
- Clinically significant coronary artery disease requiring revascularization
- 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.
- Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
- Endocarditis within 180 days prior to the study procedure
- Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
- Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
- Renal insufficiency and/or renal replacement therapy
- Leukopenia, anemia, thrombocytopenia
- Inability to tolerate or condition precluding treatment with antithrombotic therapy
- Hypercoagulable state or other condition that increases risk of thrombosis
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
- Subject refuses blood products
- Body mass index \> 50 kg/m2
- Estimated life expectancy \< 24 months
- Female who is pregnant or lactating
- Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Participating in another investigational drug or device study that has not reached its primary endpoint
- Subject considered to be part of a vulnerable population
Key Trial Info
Start Date :
January 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2038
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06167213
Start Date
January 1 2027
End Date
March 1 2038
Last Update
December 22 2025
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