IMACS Users' Guide – Version 1.0 - The International Society for ...

IMACS Users’ Guide – Version 1.0
12/21/2012
Page 12 of 56
Screening Log
United States
□ Patient did not sign the informed consent. Select reason(s) why patient was not
consented:
International
□ Too sick pre-implant and died early post implant
□ Missed opportunity to consent
□ Patient refused
□ Patient is unable to communicate in English
Each participating institution will provide IMACS with documentation of
Institutional Review Board (IRB) approval and follow their site’s guidelines for
obtaining informed consent. The institution will provide IMACS with
documentation if the IRB waives the informed consent process.
If an institution requires consent and consent was not collected then please
complete the information below:
1. Date of Implant: Enter the patient’s implant date in MMDDYYYY format.
2. Device Brand: Select the implanted device from the drop down provided. If
Other, Specify is selected, then type in the implanted device in the block
provided. (see list provided under inclusion section)
3. Device Type: Enter the appropriate device side for this implant
□ LVAD □ RVAD □ LVAD + RVAD (same OR visit) □ Total Artificial Heart
4. Age range (years): Select the appropriate age range below for the patient’s age
at time of implant:
□ 0 to21 □ 22 to 39 □ 40 to 59 □ 60 to 79 □ 80+
5. Gender: Click the appropriate box to indicate the implant patient's gender.
□ Male □ Female
6. Did death occur within 2 days post implant? Select the appropriate answer
□ Yes □ No