Conscious Sedation Study

The Sub-Study is a prospective single arm trial evaluating a conscious sedation protocol. The Sub-Study will evaluate the safety and performance of the CLAAS device using conscious sedation in comparison with the device delivery safety and performance observed in the CLAAS arm of the RCT. The Sub-Study will be performed in accordance with all protocol requirements and all subjects will be evaluated for Primary Endpoint based on the product performance at the 45 days post procedure assessment. Enrollment in the Sub-Study will not commence until enrollment in the randomized cohort is complete, initial safety of the CLAAS system is confirmed by the DSMB and FDA approval of the Sub-Study has been granted through an IDE Supplement. All subjects enrolled in the conscious sedation single arm study will follow the same clinical protocol requirements and follow-up as the randomized subjects. The Sub-Study will be identified by an NCT that is separate from the RCT with Roll-in.