Testing SAPIEN X4/X4S THV for aortic valve insufficiency

Exclusion

• −Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
• −Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
• −Failing valve has moderate or severe paravalvular regurgitation
• −Failing valve is unstable, rocking, or not structurally intact
• −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
• −Increased risk of THV embolization
• −Surgical or transcatheter valve in the mitral position
• −Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
• −Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
• −Left ventricular ejection fraction \< 20%
• −Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• −Increased risk of coronary artery obstruction after THV implantation
• −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 is not considered an exclusionExclusion criteriaThe things that would prevent someone from taking part.Read more →.
• −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
• −Subject refuses blood products
• −Body mass index \> 50 kg/m2
• −Estimated life expectancy \< 24 months
• −Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpointEndpointThe specific thing a study measures to answer its question.Read more → assessments
• −Participating in another investigational drug or device study that has not reached its primary endpointPrimary endpointThe single main question the study is designed to answer.Read more →
• −Subject considered to be part of a vulnerable population
• −Female who is pregnant or lactating