CONFORM Trial Protocol Revision M

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CONFORM Investigators and Coordinators,

The CONFORM Pivotal Trial has revised the protocol and is making effective Revision M.

Important things to know

The key changes between Revision K and Revision M are:
- Removal of the word "circumferential" as it refers to pericardial effusions
- Addition of "Device Related Thrombus" and "Myocardial Infarction" to the Adverse Events of Special Interest
- Clarification of imaging requirement if CT is used in lieu of TEE
- Clarification regarding use of historical CT and TEE for screening imaging
Detailed changes can be reviewed in the redlines (linked below)
The ICF update is limited to changing "Protocol Rev K" to "Protocol Rev M" in the document footer. There are no content changes to the ICF.

If your site uses WCG IRB and permits the Sponsor to submit on your behalf:

The protocol is now approved. Outcome documents for your site will be transmitted by WCG in the coming days.
The protocol and related documents are linked below.

If your site uses a local IRB and/or uses WCG but does not permit the Sponsor to submit on your behalf:

Please submit the new protocol revision and ICF (linked below) at your earliest convenience and alert your site manage.

Next Steps for All Sites

Provide a signed Protocol Rev M Signature Page
(linked below) to your Site Manager at your earliest convenience.

Provide signed training logs for all site staff
(read & acknowledge training is acceptable)

Additional notes:

The roll-out of Protocol Revision M should not interfere with the screening and procedures for subjects. (That is, if patients are already consented under Protocol Revision K, they should be screened and proceed to implant procedure under Protocol Revision K).
Already enrolled subjects will not be required to re-consent (please note: if your local IRB requires re-consent, re-consent is required)
The update to the protocol does not require any changes to the budget or CTA

Protocol Rev M Document Downloads
all hyperlinked and can be found on the RC Portal for your connivence

If you have any questions, please contact your Site Manager.

Have suggestions or questions about this newsletter?

Drop us a note at info@conformalmedical.com.

CAUTION: Investigational Device

The CLAAS System is limited by Federal (or United States) law to investigational use.

© 2025 Conformal Medical, Inc.
Conformal, CLAAS, and The Shape of Stroke Prevention are registered trademarks and AcuFORM is a trademark of Conformal Medical, Inc

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