Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pi-cardia
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved valve-in-valve indication due to a failed bioprosthetic valve.
Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.
You may not be if
An excessive aortic valve leaflet Calcium morphology or anatomy not suitable for the use of the ShortCut™ device.
Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure, or severe neurological disability.
Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
