Non-valvular Atrial FibrillationNCT06168942
A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
A study testing Experimental: Laminar Left Atrial Appendage Closure System and Active Comparator: WATCHMAN / Amulet in people with Non-valvular Atrial Fibrillation and Stroke, run by Jaguar LAA, Inc. at 36 sites in United States.
Trial summary
The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation, Stroke, Systemic Embolism
- What is being tested?
- Experimental: Laminar Left Atrial Appendage Closure System and Active Comparator: WATCHMAN / Amulet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 36 sitesUnited States
- Study dates
- 19 Feb 2024to 29 Feb 2032
- 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
- Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
- CHA2DS2-VASc score greater than or equal to (>=) 2 in men and >= 3 in women
- Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
- Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
- Eligible for the protocol-specified post-procedural antithrombotic regimen
- Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements
Who cannot join
- Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- Prior cardiac surgery or any procedure that involved pericardial access
- Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (<) 30 milliliters per minute per (mL/min)/1.73 square meters (m^2) or participants with end stage renal disease who are dialysis dependent
- Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
- Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Piedmont Healthcare
Atlanta, Georgia, 30309
Emory University
Atlanta, Georgia, 30322
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Northwell Health
Bay Shore, New York, 11706
Grandview Medical Center
Birmingham, Alabama, 35243
Massachusetts General Hospital
Boston, Massachusetts, 02114
Wake Forest University Health Sciences
Charlotte, North Carolina, 28203
Bethesda North Hospital Trihealth
Cincinnati, Ohio, 45202
Lindner Clinical Trial Center/Christ Hospital
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43210
Ohio Health
Columbus, Ohio, 43214
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Baptist Health Lexington
Lexington, Kentucky, 40503
Cedars Sinai Medical Center
Los Angeles, California, 90048
Centennial Medical Center
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone Health
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University in the City of New York and The New York and Presbyterian Hospital
New York, New York, 10032
Trident Medical Center
North Charleston, South Carolina, 29406
NCH Healthcare
North Naples, Florida, 34102
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Stanford Health Care
Palo Alto, California, 94303
Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
Phoenix, Arizona, 85018
Univeristy of California Davis Health
Rancho Cordova, California, 95670
Scripps Health
San Diego, California, 92121
Providence Saint John's Health Center and the Pacific Heart Institute
Santa Monica, California, 90404
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Memorial Health University Medical Center
Savannah, Georgia, 31404
Swedish Medical Center
Seattle, Washington, 98122
Heart Rhythm Associates
Shenandoah, Texas, 77380
St Joseph Hospital and Medical Center
Tacoma, Washington, 98405
Montefiore Medical Center
The Bronx, New York, 10467
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Tucson Medical Center
Tucson, Arizona, 85712
Ascension via Christi Hospitals Wichita Inc
Wichita, Kansas, 67214
About this study
Official title: LAM202403: Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study
The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).
Read the detailed description
This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).
- Conditions
- Non-valvular Atrial Fibrillation, Stroke, Systemic Embolism
- Being tested
- Experimental: Laminar Left Atrial Appendage Closure System, Active Comparator: WATCHMAN / Amulet
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Laminar Left Atrial Appendage Closure SystemDevice
Treatment with the Laminar Left Atrial Appendage Closure System.
Active Comparator: WATCHMAN / AmuletDevice
Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.
| Study group | Role | What they receive |
|---|---|---|
| Laminar Device | Experimental | Participants will be treated with the Laminar Left Atrial Appendage Closure System. Receives: Device: Experimental: Laminar Left Atrial Appendage Closure System |
| Control left atrial appendage closure (LAAC) | Active comparator | Participants will be treated with a commercially-available LAAC device. Receives: Device: Active Comparator: WATCHMAN / Amulet |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Composite rate of all-cause mortality will be reported.
Measured: Up to 12 months
Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V
The number of participants with major bleeding, according to the BARC type III or V, will be reported.
Type III
- Type IIIa includes overt bleeding plus a hemoglobin drop of 3 to less than (<) 5 grams per deciliter (g/dL) related to bleeding and any transfusion with overt bleeding.
- Type IIIb involves overt bleeding plus a hemoglobin drop of greater than or equal to (>=) 5 g/dL related to bleeding, cardiac tamponade, bleeding requiring surgical intervention for control, or bleeding requiring intravenous vasoactive agents.
- Type IIIc includes intracranial hemorrhage, with subcategories confirmed by autopsy, imaging, or lumbar puncture, as well as intraocular bleeding compromising vision.
Type V
- Type Va: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.
- Type Vb: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.
Measured: Up to 12 months
Number of Participants With Pericardial Effusion Requiring Drainage
Participants with pericardial effusion requiring drainage will be reported. Pericardial effusion is defined as 1) Clinically non-relevant: requiring no intervention, treated pharmacologically and 2) Clinically relevant: treated with therapeutic intervention (pericardiocentesis, surgical intervention, blood transfusion) and/or result in shock or death.
Measured: Up to 12 months
Number of Participants With Device Embolization
Participants with device embolization will be reported. Device embolization is defined as movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel.
Measured: Up to 12 months
Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention
Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported.
Measured: Up to 12 Months
Number of Participants Reporting Ischemic Stroke or Systemic Embolism
Participant reporting ischemic stroke or systemic embolism will be reported. Systemic embolism is defined as acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (example; trauma, atherosclerosis, or instrumentation).
Measured: Up to 18 Months
Secondary outcomes (2)
Number of Participants With Peri-Device Flow
Peri-Device flow is defined as >= 3 mm in width which communicates beyond the device into the body of the left atrial appendage) per transesophageal echocardiogram (TEE) evaluated by independent core laboratory.
Measured: Up to 12 Months
Rate of Device-Related Thrombosis
Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging.
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start19 Feb 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion29 Feb 2032 (estimated)
Why it stopped: Potential unwrapping of the LAA post implant with clinically significant leaks.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaguar LAA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saibal Kar, MD, Principal investigator, Los Robles Health SystemDevi Nair, MD, Principal investigator, St. Bernards Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168942
- Sponsor's protocol ID
- LAM202403
- Other IDs
- LAM202403, CL-0059
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAM202403: Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study
- ClinicalTrials.gov ID
- NCT06168942
- Acronym / sponsor ID
- LAM202403
- Conditions
- Non-valvular Atrial Fibrillation, Stroke, Systemic Embolism
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Potential unwrapping of the LAA post implant with clinically significant leaks.
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Jaguar LAA, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 29 Feb 2032 (estimated)
- First posted
- 13 Dec 2023 (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 compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).
Detailed description
This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminar Device | Experimental | Device: Experimental: Laminar Left Atrial Appendage Closure SystemParticipants will be treated with the Laminar Left Atrial Appendage Closure System. |
| Control left atrial appendage closure (LAAC) | Active comparator | Device: Active Comparator: WATCHMAN / AmuletParticipants will be treated with a commercially-available LAAC device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
- CHA2DS2-VASc score greater than or equal to (>=) 2 in men and >= 3 in women
- Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
- Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
- Eligible for the protocol-specified post-procedural antithrombotic regimen
Key exclusion criteria (5 listed)
- Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- Prior cardiac surgery or any procedure that involved pericardial access
- Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (<) 30 milliliters per minute per (mL/min)/1.73 square meters (m^2) or participants with end stage renal disease who are dialysis dependent
- Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
- Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)
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 |
|---|---|---|
| Experimental: Laminar Left Atrial Appendage Closure SystemTreatment with the Laminar Left Atrial Appendage Closure System. | Device | Laminar Device |
| Active Comparator: WATCHMAN / AmuletTreatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder. | Device | Control left atrial appendage closure (LAAC) |
Primary outcome
All-Cause Mortality
Time frame: Up to 12 months
Composite rate of all-cause mortality will be reported.
Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V
Time frame: Up to 12 months
The number of participants with major bleeding, according to the BARC type III or V, will be reported. Type III 1. Type IIIa includes overt bleeding plus a hemoglobin drop of 3 to less than (<) 5 grams per deciliter (g/dL) related to bleeding and any transfusion with overt bleeding. 2. Type IIIb involves overt bleeding plus a hemoglobin drop of greater than or equal to (>=) 5 g/dL related to bleeding, cardiac tamponade, bleeding requiring surgical intervention for control, or bleeding requiring intravenous vasoactive agents. 3. Type IIIc includes intracranial hemorrhage, with subcategories confirmed by autopsy, imaging, or lumbar puncture, as well as intraocular bleeding compromising vision. Type V 1. Type Va: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious. 2. Type Vb: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.
Number of Participants With Pericardial Effusion Requiring Drainage
Time frame: Up to 12 months
Participants with pericardial effusion requiring drainage will be reported. Pericardial effusion is defined as 1) Clinically non-relevant: requiring no intervention, treated pharmacologically and 2) Clinically relevant: treated with therapeutic intervention (pericardiocentesis, surgical intervention, blood transfusion) and/or result in shock or death.
Number of Participants With Device Embolization
Time frame: Up to 12 months
Participants with device embolization will be reported. Device embolization is defined as movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel.
Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention
Time frame: Up to 12 Months
Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported.
Number of Participants Reporting Ischemic Stroke or Systemic Embolism
Time frame: Up to 18 Months
Participant reporting ischemic stroke or systemic embolism will be reported. Systemic embolism is defined as acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (example; trauma, atherosclerosis, or instrumentation).
2 secondary outcomes
Number of Participants With Peri-Device Flow
Time frame: Up to 12 Months
Rate of Device-Related Thrombosis
Time frame: Up to 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Non-valvular Atrial Fibrillation
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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.
Saibal Kar, MD principal investigator
Los Robles Health System
Devi Nair, MD principal investigator
St. Bernards Heart and Vascular Center
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Laminar Left Atrial Appendage Closure System and Active Comparator: WATCHMAN / Amulet in people with Non-valvular Atrial Fibrillation and Stroke, run by Jaguar LAA, Inc. at 36 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 6 inclusion and 5 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: paused, 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 36 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?
Results are not available in the source record.
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?
All-Cause Mortality (time frame: Up to 12 months). 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.