CONFORM Clinical Trial

The CONFORM Pivotal Trial is evaluating the CLAAS® System compared to other commercially available LAAO devices in patients with Afib.

All patients enrolled in the CONFORM Pivotal Trial will be randomized to a study group and all will receive a LAAO device. One study group will receive the CLAAS implant, and the other will receive a commercially available implant.

CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. Not for sale in any geography.

Clinical Trial Participants

Please contact your physician or enrolling site coordinator for a full list of eligibility criteria. Prior to participating, the clinical staff will review the study risks and benefits and address your questions as part of the informed consent process. As part of the trial, you’ll have several responsibilities.

Eligibility Requirements

  • Diagnosed with non-valvular atrial fibrillation
  • At an increased risk for stroke and recommended for oral anticoagulation
  • Willing to comply with study protocol, including medication regimen and follow-up evaluations

Participant Responsibilities

  • Provide informed consent
  • Adhere to antiplatelet and/or oral anticoagulant therapy study requirements
  • Commit to specific follow-up intervals