Intermacs Appendices

Appendix A – Adverse Event Definitions

• Adverse Event Definitions

Appendix F – Quality of Life Questionnaires

EQ-5D: Please contact the DCC for a copy of the EQ-5D survey

English Adult Quality of Life Questionnaire

• Pre-Implant QoL Questionnaire
• Post Implant QoL Questionnaire

Spanish Adult Quality of Life Questionnaire

• Pre-Implant QoL Questionnaire
• Post Implant QoL Questionnaire

Appendix G – Trail Making Test (Part B)

• Trail Making Sample B
• Trail Making Part B
• How to Administer the Trail Making Test

Appendix I – Stroke Scales

• Modified Rankin Scale
• NIH Stroke Scale
• Stroke Scale Instructions

Appendix J – Data Access Request

Click here for more information in regards to Data Access Requests

Appendix K – Device Brand List

• Device Brand List

Appendix M – Intermacs Users’ Guide

• Intermacs FAQ User’s Guide – updated 9/18/2024
• Intermacs and Pedimacs WBDE Training

Appendix N – Pedimacs Users’ Guide

Pedimacs only. Click here for Pedimacs appendices.

Appendix O – Profiles of Advanced Heart Failure

• Patient Profile at Time of Implant

Appendix P – Intermacs Data Collection Forms – V6

• Screening Log
• Demographics
• Preimplant
• Implant
• Implant Discharge
• 1 Week Followup
• 1 Month Followup
• 3 Month Followup
• 1 Year Post Cessation
• Adverse Event
• Patient Transfer
• Withdraw Consent
• Surgeons Worksheet – Implant Form

Data Collection Forms Archive
Major Infection Slides

Appendix Q – Pedimacs Data Collection Forms

Pedimacs only. Click here for Pedimacs appendices.

Appendix R – Clinical Center Responsibilities for Medical Device Reporting

• Center MDR Responsibilities

Appendix S – Miscellaneous

• Approval Letter
• RVAD Changes