An international, multicenter, prospective, randomized clinical investigation to evaluate the safety and effectiveness of the Conformal CLAAS System for left atrial appendage occlusion, in comparison to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation.
Sponsor
Primary endpoints
- Safety endpoint: Composite of
- Major Procedure-Related Complications (cardiac perforation, pericardial effusion requiring drainage, ischemic stroke, device embolization, and major vascular complications)
- Major bleeding
- And all-cause death through 12 months post-procedure
- Effectiveness endpoint: Composite of
- Ischemic stroke
- And systemic embolism through 18 months
CERC Services
- Clinical trial documentation
- Monitoring activities
- Project management
- Regulatory submissions
Countries
USA, Georgia, Uzbekistan, Czech Republic, France
Number of investigational sites
Up to one hundred (100) investigational sites in North America, five (5) sites in Japan, and up to ten (10) sites in EU/EEA and Central Asia
