5 Year Observation of Patients With PORTICO Valves

Inclusion Criteria

• Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
• Patient has been referred for a Portico Valve implant as per Heart Team decision or patient has received a Portico Valve as per participation in an SJM sponsored regulatory or first-in-human trial.
• Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria*:
• An initial aortic valve area (AVA) of less than or equal to (≤) 1.0 cm2 (or indexed EOA less than or equal to (≤) 0.6 cm2/m2) AND
• A mean gradient greater than (>)40 mmHg or jet velocity greater than (>)4.0 m/s or Doppler Velocity Index less than ( 40 mmHg." (Baseline measurement taken by echo within 6 months of index procedure.)
• Patient has a life expectancy more than (>) 12 months.

For patients enrolled in a French site:

• Patient is at high risk for surgery as demonstrated by a Logistic EuroSCORE equal or more than (≥) 20 and/or a Society of Thoracic Surgeon (STS) mortality risk score of more than (>) 10% and/or by clinical judgment of the Heart Team based on the individual risk profile (comorbidities).
• Not applicable for a patient who has received a Portico Valve as per participation in an SJM sponsored Regulatory or First-In-Human trial.

Exclusion Criteria

• Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any "off-label" use).
• Patient has any other aortic valve than tricuspid one.
• Patient has a prosthetic valve or ring in the aortic position.
• Patient needs a concomitant structural heart procedure..
• Patient needs the usage of an embolic protection device.
• Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
• Patient is pregnant