Study ID: Conformal CLAAS EFS
The Conformal Left Atrial Appendage Seal (CLAAS™) early feasibility study is evaluating the safety and technical performance of the Conformal left atrial appendage seal for left atrial appendage occlusion.
This study is for patients diagnosed with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism. The trial tests whether the CLAAS device implant improves patients’ health outcomes.
Following implantation of the device in the heart, participants will be followed prior to hospital discharge, and then at seven days, 45 days, six months, 12 months, and at two, three, four, and five years post procedure. Transesophageal echocardiographic (TEE) follow-up will be performed at 45 days and 12 months.
This is a prospective, multicenter, open-label, single-arm, first-in-human study aimed at examining the performance of the Conformal Left Atrial Appendage Seal (CLAAS™) device for Left Atrial Appendage (LAA) closure. The device is a permanent implant designed to close the LAA to eliminate blood flow into and from the LAA.
Eligible patients include those presenting with non-valvular atrial fibrillation who are at increased risk for stroke based on CHADS2 or CHA2DS2-VASc scores and who have an appropriate rationale to seek a non-pharmacological alternative to OAC.
Other inclusion and exclusion criteria apply.
- Must have been diagnosed with non-valvular atrial fibrillation
- Must be willing to have the device implanted in their heart
- Must be willing to undergo follow-up care for up to five years