Atrial FibrillationNCT05224375
A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
A study testing Left Atrial Appendage Closure in people with Atrial Fibrillation, run by Laminar, Inc. at 1 site in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Left Atrial Appendage Closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGeorgia
- Study dates
- 9 Dec 2021to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 36Show fewer
- 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
- Recent (within 30 days pre-procedure) or planned (within 60 days postprocedure) cardiac or non-cardiac interventional or surgical procedure
- Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
- 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
- Atrial septal defect that warrants closure
- High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (exclusion >15 mm or length > 15 mm) or large shunt (early [within 3 beats] or substantial passage of bubbles)
- Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)
- Complex atheroma with mobile plaque of the aorta
- Anatomic conditions that would prevent performance of a LAA occlusion procedure (e.g., prior atrial septal defect (ASD) or patent foramen ovale (PFO) surgical repair or implanted closure device, or obliterated or ligated left atrial appendage).
- Vascular access precluding delivery of implant with catheter-based system
- Subject with inferior vena cava (IVC) filter that would interfere with Laminar sheath insertion
- Patient is unable to undergo general anesthesia
- Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment
- Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium, gold) or that would preclude any P2Y12 inhibitor therapy (e.g., clopidogrel, ticlopidine, ticagrelor, prasugrel)
- The patient has contrast sensitivity that cannot be adequately premedicated
- Bleeding diathesis or coagulopathy
- Thrombocytopenia (platelet count <75,000 cells/mm3), thrombocytosis (>700,000 cells/mm3), or leukopenia (white blood cell count <3,000 cells/mm3)
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to 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 2 years
- Current participation in another investigational drug or device study
- Vulnerable Patients groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of refusal to participate, such as students, residents, and employees)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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 12 months after the procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Left Atrial Appendage Closure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage ClosureDevice
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure System
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system. Receives: Device: Left Atrial Appendage Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days and 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start9 Dec 2021
- Primary completion5 Apr 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laminar, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224375
- Sponsor's protocol ID
- CL-0039
- Status last verified
- Sep 2025
- First submitted
- 25 Jan 2022
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05224375
- Acronym / sponsor ID
- CL-0039
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Laminar, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 12 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Left Atrial Appendage ClosureClosure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Atrial Appendage ClosureClosure of the left atrial appendage with the Laminar Left Atrial Appendage Closure System | Device | Treatment |
Primary outcome
Closure success using the Laminar Left Atrial Appendage Closure System
Time frame: 45 days
Confirmation of functional LAA closure as defined by absence of residual peri-device flow ≤ 5mm in width per transesophageal echocardiography.
Adverse Events
Time frame: 7 days and 45 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Atrial Appendage Closure in people with Atrial Fibrillation, run by Laminar, Inc. at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure success using the Laminar Left Atrial Appendage Closure System (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.