Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF

NCT04684212 | Withdrawn FDA Device

• 1 other identifier: G-200316
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to demonstrate the safety and efficacy of the implantation of the LAmbre PlusTM device in patients with large or irregularly shaped appendages with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism compared to oral anticoagulation (OAC).

Conditions

Atrial Fibrillation; Left Atrial Appendage Thrombosis; CVA

Keywords

LAMBRE device; Left Atrial Appendage Occlusion device; CVA prevention; Atrial Fibrillation; Cardiovascular angiography; Anti-coagulation management; Thromboembolism; nonvalvular atrial fibrillation; non-pharmacological alternative; Thrombosis

Outcome Measures

Primary Outcomes (3)

• Composite of time to first occurrence of stroke, cardiovascular death, or clinically relevant major or non-major bleeding events

  Defined as composite of: First occurrence of stroke defined by NeuroARC; Cardiovascular death defined as any death due to proximate cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment; Clinically relevant major or non-major bleeding events defined by hemoglobin of ≥2.0 g/dl during a 24-h period, transfusion of ≥2 units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding

  through study completion, up to 5 years

• Composite of time to first occurrence of ischemic stroke or systemic embolism

  Defined as composite of: First occurrence of ischemic stroke defined by NeuroARC; Systemic embolization 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 (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.

  through study completion, up to of 5 years

• Overall safety

  Overall safety is defined as the composite of: Major procedure-related complications, defined as the composite of cardiac perforation, pericardial effusion with tamponade, device embolization, and major vascular complications (adjudicated by the independent Clinical Events Committee as related to the study device or procedure); AND Major adverse events, defined as all death, all stroke and major bleeding as compared to OAC

  12 months

Secondary Outcomes (15)

• Mortality

  45 days, 6 months, 12 months, 5 years

• Myocardial Infarction

  45 days, 6 months, 12 months, 5 years

• Peri-Procedural Stroke

  30 days

• Bleeding Complications

  45 days, 6 months, 12 months, 5 years

• Major Procedure-Related Complications

  45 days

Study Arms (3)

Device Arm

EXPERIMENTAL

The LAmbre PlusTM Left Atrial Appendage Closure System (LAmbre device)

Device: LAmbre PlusTM Left Atrial Appendage Closure System

Control Arm

ACTIVE COMPARATOR

Market approved oral anticoagulation (OAC)

Drug: Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)

Roll-in Arm

OTHER

225 roll-in subjects

Device: LAmbre PlusTM Left Atrial Appendage Closure System

Interventions

LAmbre PlusTM Left Atrial Appendage Closure System DEVICE

The LAmbre Plus device is a self-expanding occluder, composed of a distal Umbrella and a proximal Cover laser welded together, delivered percutaneously via femoral venous access and trans-septal puncture. The distal Umbrella consists of an elastic nitinol frame and outer PET membrane, and has circumferential anchors to secure the occluder to the left atrial appendage (LAA) wall. The proximal Cover is a disc of elastic nitinol mesh, which seals the orifice of the LAA and minimizes thrombus formation, and includes a PET membrane to prevent the passage of blood into the LAA after implantation.

Also known as: LAmbre device

Device Arm; Roll-in Arm

Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa) DRUG

Continuation of market approved OAC drug.

Also known as: OAC

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is a male or non-pregnant female ≥18 years of age
• The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation or flutter
• The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
• The patient is deemed by their physician to be suitable for short-term OAC, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation
• The patient is deemed suitable for LAA closure in a shared decision model with a non-implanting physician
• The patient is willing and able to comply with protocol-specified treatment and follow-up evaluations
• The patient (or his or her legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
• Potential subjects will be excluded if ANY of the following conditions apply:

You may not qualify if:

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test
• Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism)
• Patients who require long-term anticoagulation/DAPT for a condition other than atrial fibrillation
• Patients not suitable for short term oral anti-coagulation (including due to bleeding diathesis or coagulopathy or absolute contraindication to OAC or DAPT ) or who will refuse transfusion
• Patients with rheumatic mitral valve disease, known severe aortic stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis
• Active infection with bacteremia
• Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin/bivalirudin, any device material or component (nitinol, nickel, titanium, PET), and/or contrast sensitivity that cannot be adequately pre-medicated
• Anatomic conditions that would prevent performance of the LAA occlusion procedure (e.g., prior atrial septal defect \[ASD\] or patient foramen ovale \[PFO\] surgical repair or implanted closure device, or obliterated left atrial appendage)
• Recent (within 30 days pre-procedure) or planned (within 60 days post procedure) cardiac or non-cardiac interventional or surgical procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, cataract surgery, etc.)
• Recent (within 90 days pre-procedure) stroke, transient ischemic attack, or myocardial infarction
• Severe heart failure (New York Heart Association Class IV)
• Known asymptomatic carotid artery disease with\>70% diameter stenosis OR symptomatic carotid disease (\>50% diameter stenosis with ipsilateral stroke or TIA). Subjects with prior carotid endarterectomy or carotid stent placement may be enrolled, provided that known diameter stenosis is \<50%.
• Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant
• Current participation in another investigational drug or device study
• Size of the left atrial appendage at the LAmbre Plus defined landing zone within outside the manufactures recommendations (Table 2.)

Sponsors & Collaborators

• Brian O'Neill MD: lead
• Lifetech Scientific (Shenzhen) Co., Ltd.: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (41)

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MeSH Terms

Conditions

Atrial Fibrillation; Thromboembolism; Thrombosis

Interventions

Warfarin; Dabigatran; Rivaroxaban; apixaban; edoxaban; betrixaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Benzimidazoles; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Brian O'Neill, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Interventional Cardiology Research

Model Details: This prospective, randomized, multicenter study will enroll 2,931 subjects (2706 randomized subjects, 225 roll-in subjects) at up to 75 investigational sites in the United States.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 24, 2020
• Study Start: June 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 11, 2024
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)