Additional CONFORM Trial Resources
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contact provided below.
For general information, see Learn About Clinical Studies. For additional information on the CONFORM Pivotal Trial and to view a listing of study centers, please visit ClinicalTrials.gov (keyword “CONFORM Trial” or Identifier #: NCT05147792)
Frequently Asked Questions
How do I know if I qualify for the CONFORM Clinical Trial?
If you have non-valvular AFib and are on blood thinners, speak with your doctor to learn if you are eligible to participate in the CONFORM Clinical Trial.
What should I expect if I participate?
As part of the trial, you will be asked to: Provide informed consent, Adhere to medication therapy study requirements, Commit to specific follow-up visits.
What happens if I decide to not participate?
Participation in this trial is completely voluntary. If you decide not to participate, your doctor will continue to ensure you get appropriate care.
Will I be able to get an MRI if I need it?
The CLAAS Implant is MR Conditional. A patient with the CLAAS Implant may be safely scanned. See the MR Conditional guide for more information. View Here
What are my other treatment options?
If you are seeking therapy to reduce your Afib stroke risk your options include:anticoagulants (blood thinners), commercially approved LAA closure devices, or participation in this study.
Why should I participate in a Clinical Trial?
Participating in a clinical trial provides access to highly personalized care, with expert medical teams closely monitoring your health and progress. This individualized attention ensures that your well-being is a top priority throughout the study. Alongside this dedicated care, clinical trials may also offer access to innovative treatments that have yet to be widely available. By joining a clinical trial, you benefit from exceptional medical support and contribute to advancing research that could improve healthcare for others in the future.
What are the risks?
The risks of delivery of the CLAAS AcuFORM Implant are similar to those of other procedures that require a transseptal puncture and transcatheter delivery of an implant through the venous system, across the interatrial septum, and into the left atrium using a specialized catheter (e.g. procedures and/or other LAA devices).
Discuss with your doctor the risks and benefits of participating in a clinical trial.
CAUTION: Investigational Device The CLAAS System is limited by Federal (or United States) law to investigational use.
Contact Information
Conformal Medical, Inc.
15 Trafalgar Square Suite 101
Nashua, NH 03063