Stroke Clinical Trial - Laminar LAAX Pivotal IDE Study

Status Enrolling by invitation

Clinical Trial Summary

The goal of this clinical trial is to compare the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices. This procedure is for patients with non-valvular atrial fibrillation who are at increased risk for stroke, but have a reason to seek an alternative to blood thinning medications. This clinical trial will compare the safety and efficacy of the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices. Participants in this trial will be randomly assigned one-to-one (like flipping a coin) for treatment with either the Laminar Left Atrial Appendage Closure System or a commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).

Clinical Trial Description

This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder). The study will randomize 1,500 eligible participants at up to 100 sites in the United States. After implantation of left atrial appendage closure device, participants will be continued on appropriate medical therapy per guidelines or best local practices. Participants will be followed for 5 years after device implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06168942
Study type	Interventional
Source	Laminar, Inc.
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	February 22, 2024
Completion date	February 2032

View Details

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