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

NCT05224375 | Completed FDA Device

• 1 other identifier: CL-0039
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation that cannot take, or a have a reason to seek an alternative to anticoagulant medications.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Closure success using the Laminar Left Atrial Appendage Closure System

  Confirmation of functional LAA closure as defined by absence of residual peri-device flow ≤ 5mm in width per transesophageal echocardiography.

  45 days

• Adverse Events

  Rate of all cause-mortality and major adverse events (including procedure-related stroke, systemic embolism, life-threatening or major bleeding) and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.

  7 days and 45 days

Study Arms (1)

Treatment

EXPERIMENTAL

Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system.

Device: Left Atrial Appendage Closure

Interventions

Left Atrial Appendage Closure DEVICE

Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure System

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with documented Non-Valvular AF, defined as AF (paroxysmal, persistent, or permanent) in the absence of moderate-to-severe mitral stenosis or a mechanical heart valve.
• Subject must be ≥18 years of age.
• Subject has a calculated CHA2DS2-VASc score of 2 or greater, denoting a high risk for stroke or systemic embolism.
• Subject is recommended for chronic oral anticoagulation therapy (OAC), but is non eligible or has an appropriate rationale to seek a non-pharmacologic alternative to chronic OAC
• Subject deemed appropriate for LAA closure by the Site Heart Team
• Subject is eligible for the post-procedural antithrombotic regimen per protocol
• Subject (or legally authorized representative, (where allowed)) has been informed of the nature of the study, agrees to its provisions, is willing and able to comply with the protocol-required medications and follow-up visits, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

You may not qualify if:

• AF single episode or transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• Recent (within 90 days pre-procedure) stroke or transient ischemic attack
• Subject with history of acute or recent myocardial infarction (MI) or unstable angina within 90 days
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, or dialysis at the time of screening
• Active infection with bacteremia
• Active COVID-19 infection
• Cardiac tumor
• Subject with a history of pericarditis, rheumatic heart disease, or severe cardiac valvular disease
• Medical condition (other than AF) that mandates chronic oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
• Severe heart failure (New York Heart Association Class III or IV)
• Documented symptomatic carotid artery disease (\>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of \>70%)
• Prior cardiac surgery, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
• Previous AF Ablation procedure in the 90 days before the LAMINAR procedure date
• Need for AF Ablation procedure to be performed less than 90 days from the LAMINAR procedure
• Subject with a history of coronary artery bypass graft (CABG) surgery

Sponsors & Collaborators

• Laminar, Inc.: lead

Study Sites (1)

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: December 9, 2021
• Primary Completion: April 5, 2023
• Study Completion: February 15, 2024
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)