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NCT05565599Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
58 (actual)
First submitted
29 Sept 2022
Start date
21 Oct 2022
Primary completion date
7 Aug 2024
Lead sponsor
Jaguar LAA, Inc.
NCT number
NCT05565599

What you commit to

  • Study type: Interventional
  • Participants enrolled: 58
  • From 21 Oct 2022 to the primary completion date, 7 Aug 2024
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Stroke or transient ischemic attack within 90 days before the index procedure
  • Myocardial infarction or unstable angina within 90 days before the index procedure
  • Confirmed coronavirus disease 2019 (COVID-19) infection within 10 days before the index procedure Coexisting Cardiovascular Disease
  • 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
  • Vascular access precluding delivery of implant with catheter-based system
  • 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
  • Current participation in another investigational drug or device study that in the opinion of the investigator could confound the data interpretation

Other illness

  • Single episode, transient, or reversible AF (for example, secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  • Active infection with bacteremia
  • 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)
  • Participant with condition which precludes adequate TEE assessment
  • Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium)
  • 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

Lab values

  • 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
  • Left ventricular ejection fraction (LVEF) \<30%

Other

  • 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
  • Presence of inferior vena cava (IVC) filter that would interfere with Laminar sheath insertion
  • Participant unable to undergo general anesthesia
  • Contrast sensitivity that cannot be adequately pre-medicated
  • Thrombocytopenia , thrombocytosis, or leukopenia values as specified in protocol

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Bernard's Heart & Vascular
Coordinator of this site? Confirm its status
JonesboroUnited StatesUnknown status
Scripps Health
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Columbia University Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Icahn School of Medicine at Mt. Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Univeristy of California Davis Health
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
Cardiovascular Institute Los Robles Hospital and Medical Center
Coordinator of this site? Confirm its status
Thousand OaksUnited StatesUnknown status
Tucson Medical Center
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.