Evaluating the Safety and Effectiveness of the Conformal CLAAS System Compared to WATCHMAN and Amulet Devices for Left Atrial Appendage Closure in Adults with Atrial Fibrillation

What this Trial Is About

Researchers are evaluating the safety and performance of the Conformal CLAAS device compared to the commercially available WATCHMAN and Amulet left atrial appendage closure devices in patients with non-valvular atrial fibrillation at high risk of stroke. The study aims to establish that the CLAAS device is not worse than these other devices in preventing stroke and related complications. Participants eligible for the study will be randomized to receive either the CLAAS device or one of the comparator devices and will be followed for a total of five years after implantation. Participants will undergo a procedure to implant one of the left atrial appendage closure devices via a catheter-based system. The study includes two groups one receiving the CLAAS device and the other receiving either the WATCHMAN or Amulet device. After implantation, patients will be monitored closely for safety and effectiveness outcomes, including procedure-related complications and stroke prevention over time. The study involves careful follow-up visits and assessments to track device success and any adverse events. Throughout the study, participants will have regular evaluations to monitor outcomes such as procedure complications, death, major bleeding, ischemic stroke, and systemic embolism, with primary outcome assessments at 12 and 18 months and extended follow-up up to five years. Success of the device placement and technical performance will also be assessed at various time points. Participants will be asked to follow medication regimens and attend follow-up visits to ensure proper monitoring. The total duration of participation includes post-procedure monitoring and long-term outcome measurement extending to the end of the study period.

The CONFORM Pivotal Trial