Non-valvular Atrial FibrillationNCT05565599
An Early Feasibility Study Evaluating the Safety and Efficacy 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 Non-valvular Atrial Fibrillation, run by Jaguar LAA, Inc. at 7 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular 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
- 58 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Oct 2022to 9 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
St. Bernard's Heart & Vascular
Jonesboro, Arkansas, 72401
Scripps Health
La Jolla, California, 92037
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Univeristy of California Davis Health
Sacramento, California, 95817
Cardiovascular Institute Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360
Tucson Medical Center
Tucson, Arizona, 85712
About this study
Official title: CL0043: An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
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.
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- Left Atrial Appendage Closure
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.
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.
Measured: 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.
Measured: 12 months
LAA Closure Rate
Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
Measured: 45 days
LAA Closure Rate
Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
Measured: 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.
Measured: 45 days
Composite of Ischemic Stroke or System Embolism
Composite of ischemic stroke or systemic embolism.
Measured: 12 months
Secondary outcomes (2)
Device-Related Thrombus
Rate of device-related thrombus (DRT) per CCTA evaluated by independent core laboratory.
Measured: 45 days
Device-Related Thrombus
Rate of DRT per TEE evaluated by independent core laboratory.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start21 Oct 2022
- Primary completion7 Aug 2024
- Study completion9 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaguar LAA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biosense Webster, Inc. Clinical Trial, Study director, Biosense Webster, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565599
- Sponsor's protocol ID
- CL0043
- Other IDs
- CL0043, LAM202404
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CL0043: An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05565599
- Acronym / sponsor ID
- CL0043
- Conditions
- Non-valvular Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Jaguar LAA, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 9 Sep 2028 (estimated)
- First posted
- 4 Oct 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.
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.
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.
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)
- 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
Key exclusion criteria (28 listed)
- 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
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
Composite Adverse Events
Time frame: 45 days
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.
Composite Adverse Events
Time frame: 12 months
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.
LAA Closure Rate
Time frame: 45 days
Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
LAA Closure Rate
Time frame: 12 months
Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
LAA Closure Rate
Time frame: 45 days
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.
Composite of Ischemic Stroke or System Embolism
Time frame: 12 months
Composite of ischemic stroke or systemic embolism.
2 secondary outcomes
Device-Related Thrombus
Time frame: 45 days
Device-Related Thrombus
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
Biosense Webster, Inc. Clinical Trial study director
Biosense Webster, Inc.
7 sites 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 Non-valvular Atrial Fibrillation, run by Jaguar LAA, Inc. at 7 sites in United States.
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 28 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite Adverse Events (time frame: 45 days). The study lists 6 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 19 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.