An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation

NCT05565599 | Active Not Recruiting FDA Device

• 1 other identifier: CL0043
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 7

Brief Summary

This is an early feasibility 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

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (6)

• Composite Adverse Events

  Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.

  45 days

• Composite Adverse Events

  Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.

  12 months

• LAA Closure Rate

  Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.

  45 days

• LAA Closure Rate

  Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.

  12 months

• LAA Closure Rate

  Rate of LAA closure per CCTA evaluated by independent core laboratory. Contrast patency defined as LAA density ≥100 HU or ≥25% of that of the left atrium.

  45 days

• Composite of Ischemic Stroke or System Embolism

  Composite of ischemic stroke or systemic embolism.

  12 months

Secondary Outcomes (2)

• Device-Related Thrombus

  45 days

• Device-Related Thrombus

  12 months

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:

• Documented non-valvular atrial fibrillation (AF), defined as AF (paroxysmal, persistent, or permanent) in the absence of moderate-to-severe mitral stenosis or a mechanical heart valve
• Participant greater than or equal to (\>=)18 years old
• CHA2DS2-VASc score \>=2 in men and \>= 3 in women
• Participant is recommended for chronic oral anticoagulation therapy (OAC) but is not eligible or has an appropriate rationale to seek a non-pharmacologic alternative to chronic OAC
• Participant deemed appropriate for LAA closure by the Site Heart Team using an evidenced based decision-making tool
• Participant eligible for the protocol-specified post-procedural antithrombotic regimen
• Participant or Legally Authorized Representative informed of the nature of the study, is willing and able to comply with the protocol, and has provided written informed consent per Institutional Review Board (IRB) requirements

You may not qualify if:

• Single episode, transient, or reversible AF (for example, secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• Stroke or transient ischemic attack within 90 days before the index procedure
• Myocardial infarction or unstable angina within 90 days before the index procedure
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (\<)30 milliliters per minute (mL/min)/1.73 sqaure meter (m\^2), or dialysis at the time of screening
• Active infection with bacteremia
• Confirmed coronavirus disease 2019 (COVID-19) infection within 10 days before the index procedure Coexisting Cardiovascular Disease
• Cardiac tumor
• History of mitral valve or other severe cardiac valvular disease requiring intervention or presence of prosthetic mechanical valve
• 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 IV)
• Symptomatic carotid artery disease (greater than \[\>\] 50 percent \[%\] diameter reduction with prior ipsilateral stroke or transient ischemic attack \[TIA\]) or asymptomatic carotid artery disease (diameter reduction of \>70%) Previous or Planned Interventions
• Previous AF ablation procedure in the 90 days before the index procedure date or need for AF ablation to be performed in less than 90 days after the index procedure
• Recent (within 30 days before the index procedure) or planned (within 60 days after the index procedure) cardiac or non-cardiac interventional or surgical procedure
• Intracardiac thrombus or dense spontaneous echo contrast visualized by transesophageal echocardiographic (TEE) within 2 days before the index procedure
• Left ventricular ejection fraction (LVEF) \<30%

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (7)

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

St. Bernard's Heart & Vascular

Jonesboro, Arkansas, 72401, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Univeristy of California Davis Health

Sacramento, California, 95817, United States

Location

Cardiovascular Institute Los Robles Hospital and Medical Center

Thousand Oaks, California, 91360, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

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: September 29, 2022
• First Posted: October 4, 2022
• Study Start: October 21, 2022
• Primary Completion: August 7, 2024
• Study Completion (Estimated): September 9, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (7)