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Conscious Sedation Study

NCT06049615 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Conformal Medical, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-08-01
Primary Completion
2028-05-01
Completion
2028-08-01
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06049615 on ClinicalTrials.gov