NCT06049615

Conscious Sedation Study

The Conscious Sedation Single Arm Sub-Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Conformal Medical, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Conscious Sedation Single Arm Sub-Study is designed to evaluate the safety and performance of the CLAAS device implantation procedure using conscious sedation.

Detailed description

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	CLAAS® System	The CLAAS® System delivers a plug to the ostia of the Left Atrial Appendage (LAA) and is designed to occlude the appendage to eliminate blood flow. It is designed to conform to the geometry of the LAA. The implant is designed to permanently seal off the LAA from the LA with an endothelial layer that forms across the LA face of the implant. The implant is available in two different sizes; Regular (27mm) and Large (35mm) to accommodate patient anatomy. Angiography and/or echocardiography may be used to determine the LAA ostium diameter to properly select the Implant size. The implant has an inner, cylindrical, Nitinol endoskeleton that provides the mechanical base structure. The Nitinol endoskeleton contains 10 face struts and 20 anchors (Regular) and 12 struts and 24 anchors (Large) facing proximally to engage the tissue to resist movement. The endoskeleton also provides the conformable structure to enable the foam cylinder to compress against the LAA tissue to facilitate sealing.

Timeline

• Start date: 2027-08-01
• Primary completion: 2028-05-01
• Completion: 2028-08-01
• First posted: 2023-09-22
• Last updated: 2026-03-20

Regulatory

• FDA-regulated device study