Preoperative parameters | Surgery | Discharge | 6 months | Year 1 | Year 2 | Registry exit | Adverse events | |
---|---|---|---|---|---|---|---|---|
Signed informed consent | X | |||||||
Inclusion/exclusion criteria | X | |||||||
Baseline characteristics | X | |||||||
Demographics and vital signs | X | |||||||
Medical historya | X | |||||||
Echo valve pathology | X | |||||||
Laboratory/Symptoms | X | X | X | X | ||||
MRI | X | X | X | |||||
Access (Operative data) | X | |||||||
Discharge data | X | |||||||
Echocardiogram (TTE) | X | X | X | X | X | |||
Echo form | X | X | X | X | ||||
6 Minute Walk Test | X | X | X | |||||
QoL questionnaire (SF-12) | X | X | X | X | ||||
Outcome questionsb | X | X | X | |||||
Expiration (death form) | X | X | X | X | ||||
Device and Patient success | X | |||||||
Registry exit | X | |||||||
Adverse events | X | X | X | X |