AltaValve Pivotal Trial

Exclusion Criteria

• •Inability to understand the trial or a history of non-compliance with medical advice.
• •Inability to provide signed Informed Consent Form (ICF).
• •History of any cognitive or mental health status that would interfere with participation in the trial.
• •Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
• •Female subjects who are pregnant or planning to become pregnant within the trial period.
• •Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
• •Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
• •Known hypersensitivity to contrast media that cannot be adequately medicated.
• •Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
• •Concurrent medical condition with a life expectancy of less than 12 months.
• •Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
• •Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.