Manual of Procedures
CONFORM IDE Trial NCT05147792
Get The Entire Manual of Procedures
Download the established operational guidelines and best practices for the CONFORM Pivotal Trial with the CLAAS® Device.
19AUG2025
Access the Individual Files of The MOP Binder
MOP 2 - Study Contact List
V9.0 18AUG2025
MOP 3 - Site Personnel Training Requirements
V7.0 18AUG2025
MOP 4 - Conformal CCGs
V2.0 14Jan2025
MOP 5 – Study Schema Table
V5.0 18AUG2025
MOP 6 - Randomization
V3.0 18AUG2025
MOP 7 - Imaging Upload
V 4.0 14JAN2025
MOP 7A - TEE Imaging Acquisition Protocol
V6.0 12MAR2024
MOP 7B - TEE Echo Checklist
V4.0 27OCT2023
MOP 7C - CT Acquisition Protocol
Rev A. 15JUN2022
MOP 8 – Device Accountability WI
V 3.0 18AUG2025
MOP 8A – Return Devices
V3.0 18AUG2025
MOP 8B – Device Accountability App
V3.0 18AUG2025
MOP 9 – Patient Implant Card
V 2.0 18OCT2023
MOP 10 - Protocol Deviations
V4.0 20MAY2025
MOP 11 - AE Adjudication Module
V 3.0 18OCT2023
MOP 12 – Pre-Procedure Review Process
V4.0 18AUG2025
MOP 12 – Appendix A Pre-Procedure Imaging Review Process Example
V5.0 05MAR2025
MOP 13 – Study Exit Flowchart
Will be provided at a later date.
MOP 14 – Submitting Planned-Scheduled Case
V1.0 20MAY2025