Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04807283

Enrollment

Registered

2021-03-19

Start date

2021-03-05

Completion date

2023-12-31

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Left Atrial Appendage Closure

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).

Interventions

DEVICELeft Atrial Appendage Closure

Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 1\. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF). * 2\. Subject must be ≥18 years of age. * 3\. Subject has a calculated CHA2DS2-VASc score of 2 or greater. * 4\. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months. * 5\. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin. * 6\. Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.

Exclusion criteria

* 1\. Subject who requires anticoagulation for a condition other than AF. * 2\. Subject with a New York Heart Association (NYHA) classification equal to IV. * 3\. 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. * 4\. Subject with valvular disease.

Design outcomes

Primary

Measure	Time frame
Freedom from device or procedure related serious adverse events	7 days
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE	45 days

Secondary

Measure	Time frame
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism	45 days and 6 months

Countries

Georgia, Paraguay

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026