|Secondary Safety End Points||Number of Procedures Meeting the End Point||Percentage|
|No MAEs during the hospital stay for the index procedure||98.46%|
|Absence of mobile left atrial thrombus or MAEs within 6 (6) months of the index procedure||98.46%|
|Secondary Effectiveness End Points|
|Device success: successful delivery and deployment of the PLAATO implant into the LAA or recapture and retrieval (if necessary.)||93.85%|
|Procedural success: device success and no MAEs during the hospital stay of the index procedure||93.85%|
|Implantation success: successful delivery and deployment of the PLAATO implant into the LAA and the absence of MAEs within 1 (1) month of the index procedure||93.85%|
|Treatment success is defined as implantation success and LAA occlusion by echocardiography at 1 (1) month||22 of 22⁎||100%|
LAA = left atrial appendage; MAE = major adverse event; PLAATO = Percutaneous Left Atrial Appendage Transcatheter Occlusion.
↵⁎ Only the first 20 patients were required by the protocol to have the seal leak assessed at the 1-month follow-up and therefore were the only patients analyzed for the treatment success end point.