CONFORM Trial Protocol Revision R

CONFORM Investigators & Research Coordinators,

We are contacting you to provide you with the updated CONFORM Manual of Procedures (MOP) documents, revised to align with current CONFORM trial processes and CONFORM Protocol Revision R.

Below is an overview of the updated documents, along with links to download each individually. You may also use the button below to download a complete PDF of the updated MOP binder.

Download the Latest MOP Binder

We hope that you find these updates useful and will continue to communicate revisions as they occur.

Manual of Procedures (MOP)
Protocol Rev. R Updated Documents

MOP02 Study Contact List V10.0 16Apr2026

Updated to reflect current Conformal Medical personnel
MOP03 Site Personnel Training Requirements V8.0 16Apr26

Updated to indicate Procedural TEE can be performed by a qualified echocardiographer (e.g. Physician echocardiologist, imaging technician, or other qualified personnel)
MOP05 Study Schema Table V6.0 16Apr2026

Updated to reflect current CONFORM Pivotal Trial Protocol Rev R
MOP07 Imaging Upload V5.0 16Apr2026

Updated to include instructions on the following:
- Automatic redaction of PHI for imaging uploads
- How to address Site Tasks in Intelemage
MOP12 Pre-Procedure Review Process V 5.0 16APR2026

Updated to align with modified streamlined process:
- Pre-procedure review process only applies for 1st CLAAS case for each implanting physician
- Pre-procedure Review slide deck is no longer required
- 1:1 Call can be made with Field Clinical Specialist
- FAQ updated for clarity
MOP13 Study Exit Flowchart V2.0 16APR2026

New Flowchart to visualize follow-up requirements for subjects in roll-in and randomized cohorts

Download the Latest MOP Binder

A full PDF of the Manual of Procedures (MOP), along with individual section PDFs, is available for download on the Research Coordinators Portal.
(Password: AcuFORM2025! )

Please note that updated hard copies will not be mailed to sites.

If you have any questions, please contact your Site Manager. Thank you for your continued support of the CONFORM Pivotal Trial.

Have suggestions or questions about this newsletter?

Drop us a note at info@conformalmedical.com.

CAUTION: Investigational Device. Limited by federal (or United States) law to investigational use. Outside the United States, the device is intended exclusively for clinical investigation. Not approved for commercial use.

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