Conscious Sedation Study

Sponsor
Conformal Medical, Inc
Study ID
NCT06049615
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLAAS® System — DEVICE
    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.

Study Details

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

Key Dates

First listed
Sep 22, 2023
Start date
Aug 1, 2027
Status verified
Mar 2026
Primary completion
May 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: CLAAS
    Subjects to be implanted with the CLAAS device.

Primary Outcome Measure

Primary Efficacy: Evaluating the Performance of CLAAS, as defined below: [ Time Frame: 7 days through 45 days post-procedure ]

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