Thank you to all sites for accommodating our monitoring team and for your continued support in keeping all data aligned and on schedule.
Tips & Reminders
Follow-up visits, please review all ongoing Adverse Events to determine whether they have resolved or resolved with sequelae and ensure you are capturing any changes to their outcomes.
Ensure all data is entered promptly after each visit, with particular attention to timely and complete documentation of the index procedure.
EnsurePre-Discharge TTE is conducted a minimum of 4 hours from the end of the procedure (removal of the access sheath). EDC will calculate to the minute!
Concomitant medications required in EDC:
Antiplatelets
Anticoagulants
Antibiotics used for endocarditis prophylaxis (i.e., during the index procedure; no need to enter AE-related antibiotics)
RIO 2025 took place online from November 20–23. During the event, Dr. Devi Nair presented a case review and led a discussion on the CLAAS AcuFORM System. The case highlighted the next-generation approach to LAAO and reinforced how the AcuFORM System is easy to size, easy to seal, and easy to verify.
We have developed a new tool to help assist Research Coordinators in communicating the benefits of the CONFORM Pivotal Trial with the CLAAS AcuFORM LAAO device.
This new guide is designed to assist you in answering questions your patients may have about participating in a clinical study.
You can find this tool on the RC Portal and in the CONFORM App
NEW CONFORM Trial with AcuFORM Patient Trifold Brochure
We’re excited to share that a new patient-focused brochure—aligned with the CONFORM Trial patient website—is now approved and in production. Provide your patients with key information about the CONFORM Trial and the CLAAS AcuFORM System, and to guide interested patients to the website to learn more.
You can find this tool on the RC Portal and in the CONFORM App
Make sure your IRB has approved the following materials before using.
Access the Research Coordinator Portal use the link below and Login with AcuFORM2025!
On November 6–7, Conformal hosted an RC Meeting with 35 RCs/LAA Coordinators across 20 sites in Nashville, TN.
Dr. Christopher Ellis and his RC team from Vanderbilt presented best practices for patient enrollment, offering RCs an unbiased perspective on the AcuFORM System and sharing how they address common enrollment questions and concerns.
Attendees learned about best practices, Protocol Reminders, and had an opportunity to meet a few peers from across the country.
While we would love to have every CONFORM site attend, we intentionally design our events to be focused and manageable—allowing us to give each attendee dedicated time and attention.
Thank you to all who were able to join us. We look forward to welcoming all our CONFORM Trial partners at future events.
Research Coordinators: please share your interest in attending an upcoming event with your Site Manager.
Have suggestions or questions about this newsletter?
The CLAAS® AcuFORM™ System is limited by federal law (United States) to investigational use. Exclusively for clinical investigation outside the United States. Not approved for commercial use.
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