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Active, not recruitingNCT05565599Updated Sep 28, 2026

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

An interventional study of Left Atrial Appendage Closure in Non-valvular Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Active, not recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Biosense Webster, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Left atrial appendage closure (LAAC) is an approved therapy for stroke prevention in atrial fibrillation patients who are recommended for chronic oral anticoagulation therapy (OAC), but are non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants in accordance with evidence-based decision-making criteria and current scientific guidelines.

The objective 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 who are deemed appropriate for LAAC to reduce the risk of stroke and systemic embolism.

Patients will be followed for 5 years after the procedure.

02

Conditions studied

  • Non-valvular Atrial Fibrillation
03

In context

Lead sponsor

Biosense Webster, Inc. is the lead sponsor of 65 studies on the registry; 10 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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%
  • Circumferential pericardial effusion >10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
  • Complex atheroma with mobile plaque of the aorta
  • Interatrial communication, atrial septal defect, or patent foramen ovale that warrants closure
  • Vascular access precluding delivery of implant with catheter-based system
  • Presence of inferior vena cava (IVC) filter that would interfere with Laminar sheath insertion
  • Participant unable to undergo general anesthesia
  • Participant with condition which precludes adequate TEE assessment
  • Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium)
  • Contrast sensitivity that cannot be adequately pre-medicated
  • Thrombocytopenia , thrombocytosis, or leukopenia values as specified in protocol
  • Pregnant or nursing and those who plan pregnancy in the period up to 1 year following the index procedure. Participants of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days before index procedure
  • Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 1 year
  • Current participation in another investigational drug or device study that in the opinion of the investigator could confound the data interpretation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Treatment

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

    Device: Left Atrial Appendage Closure

Interventions

  • DeviceLeft Atrial Appendage Closure

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 45 days

  2. 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.

    Time frame: 12 months

  3. LAA Closure Rate

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

    Time frame: 45 days

  4. LAA Closure Rate

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

    Time frame: 12 months

  5. 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.

    Time frame: 45 days

  6. Composite of Ischemic Stroke or System Embolism

    Composite of ischemic stroke or systemic embolism.

    Time frame: 12 months

Secondary outcomes

  1. Device-Related Thrombus

    Rate of device-related thrombus (DRT) per CCTA evaluated by independent core laboratory.

    Time frame: 45 days

  2. Device-Related Thrombus

    Rate of DRT per TEE evaluated by independent core laboratory.

    Time frame: 12 months

07

Study locations

7 sites
  • Tucson Medical Center
    Tucson, Arizona 85712, United States
  • St. Bernard's Heart & Vascular
    Jonesboro, Arkansas 72401, United States
  • Scripps Health
    La Jolla, California 92037, United States
  • Univeristy of California Davis Health
    Sacramento, California 95817, United States
  • Cardiovascular Institute Los Robles Hospital and Medical Center
    Thousand Oaks, California 91360, United States
  • Icahn School of Medicine at Mt. Sinai
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05565599
Lead sponsor
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Oct 4, 2022
Start date
Oct 21, 2022
Primary completion
Aug 7, 2024
Completion
Sep 9, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Biosense Webster, Inc. Clinical Trial
study director · Biosense Webster, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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