2 results
Approved WMOCompleted
Demonstrate that the observed incidence of procedure and/or device related incidence of new stroke (excludes transient ischemic attack) within 30 days of an ablation procedure (index or reablation) with the Phased RF System is less than 1.8% with…
Approved WMOCompleted
The primary objective of this second phase study is to estimate the occurrence of anastomotic leakage when the C-seal is used.Secondary objectives are:* Feasibility of applying the C-seal, especially considering the improved attachement to the…