CONFORM Trial Updates to EDC

CONFORM Research Coordinators,

Conformal has been working closely with our partners to implement updates to the EDC, all designed to enhance your experience with CONFORM Study data collection.

Your CONFORM Site Manager will reach out to walk through these changes with you and address any questions you may have about these updates to the EDC.

Below you will find at a glance overview of the EDC updates. Use the download button to access a more detailed summary.

Download the PDF Overview

EDC — Update Effective May 11th, 2026

Changes will affect patients consented under Protocol Rev. M or later

1. Adverse Event — Adverse Event of Special Interest

New field for Device Related Thrombus (affects only new subjects moving forward)

2. Death

Updated Cardiovascular death to specify Cardiac Death and Vascular Death for primary causes of death.

*Device deficiency CRFs (#3 - #4) updates are to support regulatory reporting requirements.

3. Device Deficiency Summary. Renamed form from CLAAS Device Deficiency reporting for Control device.

Added reporting instruction with guidance to include device deficiency reporting for Control device

4. Device Deficiency: Renamed form from CLAAS Device Deficiency to Device Deficiency

New field for Date Sponsor was notified
Added VizaraMed, Watchman device components, and Amulet components
Added a new field for "Could it have led to a Serious Adverse Device Effect (SADE)?"
Updated field label from "Please confirm which AE Number is related to this device deficiency" to "if yes, what is the AE #?"
Added a new field for if yes, was it a serious adverse event?
Added a new field for location of device
Added a section titled 'Action / Outcome of the device deficiency'
Enable fields under 'Action / Outcome of the device deficiency' section when condition is met

Note: the sub questions for "Did device deficiency or device malfunction occur have been removed from Control implant CRF due to the device deficiency CRF updates above.

5. CLAAS Delivery System CRF

Added Vizaramed Multiflex Steerable Sheath to options for Access Sheath/Additional Components

6. Study Exit CRF

Added a new option of no longer meets eligibility criteria for Subject Classification
- This applies for subjects that no longer meet eligibility criteria post-randomization
- These subjects will be required to be followed for 18 months

7. Informed Consent

Protocol Revisions R, S, and T are now available

8. Re-consent Log

Protocol Revisions R, S, and T are now available

9. Inclusion/Exclusion Criteria

Added EC21 and EC22 which only applies for FRANCE

10. Medical History

New option of both Cardioversion & Ablation to options for If YES, specify type.

11. Randomization

Added reminder: Prior to randomization, must be reviewed and approved by Conformal.

Download the PDF Overview

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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