Longterm Safety and Performance of the JenaValve (JUPITER)

• All-cause mortality,
• Cardiovascular mortality,
• Major stroke,
• Life-threatening or disabling bleeding,
• Major bleeding,
• Acute kidney injury,
• Myocardial infarction,
• Major vascular complication,
• Mechanical coronary obstruction,
• Prosthetic valve thrombus,
• Prosthetic valve endocarditis,
• Conduction disturbance and cardiac arrhythmia,
• Necessity of permanent pacemaker implantation

The following parameters will be collected to assess device success:

1. Successful vascular access, delivery and deployment of the device successful retrieval of the device
2. Correct position of the device in the proper anatomical location
3. Intended performance of the prosthetic heart valve:
4. Only one valve implanted in proper anatomical position

The following parameters will assess effectiveness:

• Transvalvular aortic peak pressure gradient
• Transvalvular aortic mean pressure gradient
• Effective aortic valve area
• Paravalvular regurgitation coded according to VARC
• Transvalvular regurgitation coded according to VARC
• No clinically significant valve migration/dislocation
• Absence of mechanical coronary obstruction
• Functional improvement assessment by NYHA functional classification

A combined safety endpoint will be assessed at 30 days consisting of the following variables:

• All-cause mortality
• Major stroke
• Acute kidney injury (Stage 3)
• Life-threatening or disabling bleeding
• Major vascular complication
• Peri-procedural myocardial infarction
• Repeat surgical or interventional procedure for valve-related dysfunction

A combined efficacy endpoint will be assessed consisting of the following variables:

• All-cause mortality (after > 30 days)
• Failure of current therapy for AS, requiring hospitalization for symptoms of valve-related or cardiac decompensation
• Prosthetic heart valve dysfunction