A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation

Laminar, Inc.4 sites in 2 countries29 target enrollmentMarch 5, 2021

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Laminar, Inc.
Enrollment: 29
Locations: 4
Primary Endpoint: Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).

Registry

clinicaltrials.gov

Start Date

March 5, 2021

End Date

December 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Laminar, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
•Subject must be ≥18 years of age.
•Subject has a calculated CHA2DS2-VASc score of 2 or greater.
•Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
•Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
•Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.

Exclusion Criteria

•Subject who requires anticoagulation for a condition other than AF.
•Subject with a New York Heart Association (NYHA) classification equal to IV.
•Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
•Subject with valvular disease.