Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF
NCT ID: NCT04684212
Last Updated: 2025-11-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2024-06-01
Study Completion Date
2024-07-11
Brief Summary
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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).
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Detailed Description
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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. Patients presenting with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc scores, and who are recommended for oral anticoagulation therapy but have an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, and who meet all eligibility criteria will be enrolled in the study.
Subjects will have clinical follow-up in-hospital and at 45 days, 6 months, 12 months, and annually up to 5-years. CT/Imaging or Transesophageal echocardiographic (TEE) follow-up will occur at 45 days and TEE at 1-year.
The LAmbre PlusTM Left Atrial Appendage (LAA) Closure System is intended to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation who:
* Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for oral anticoagulation (OAC) therapy; AND
* Are deemed by their physician to be suitable for OAC; AND
* Have an appropriate rationale to seek a non-pharmacological alternative to OAC, taking into account the safety and effectiveness of the device compared to OAC
Subjects will have clinical follow-up in-hospital and at 45 days, 6 months, 12 months, and annually up to 5-years. CT/Imaging or Transesophageal echocardiographic (TEE) follow-up will occur at 45 days and TEE at 1-year.
The LAmbre PlusTM Left Atrial Appendage (LAA) Closure System is intended to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation who:
* Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for oral anticoagulation (OAC) therapy; AND
* Are deemed by their physician to be suitable for OAC; AND
* Have an appropriate rationale to seek a non-pharmacological alternative to OAC, taking into account the safety and effectiveness of the device compared to OAC
Conditions
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Atrial Fibrillation
Left Atrial Appendage Thrombosis
CVA
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Device Arm
The LAmbre PlusTM Left Atrial Appendage Closure System (LAmbre device)
Group Type
EXPERIMENTAL
LAmbre PlusTM Left Atrial Appendage Closure System
Intervention Type
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.
Control Arm
Market approved oral anticoagulation (OAC)
Group Type
ACTIVE_COMPARATOR
Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
Intervention Type
DRUG
Continuation of market approved OAC drug.
Roll-in Arm
225 roll-in subjects
Group Type
OTHER
LAmbre PlusTM Left Atrial Appendage Closure System
Intervention Type
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.
Interventions
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LAmbre PlusTM Left Atrial Appendage Closure System
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.
Intervention Type
DEVICE
Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
Continuation of market approved OAC drug.
Intervention Type
DRUG
Other Intervention Names
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LAmbre device
OAC
Eligibility Criteria
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Inclusion Criteria
1. The patient is a male or non-pregnant female ≥18 years of age
2. The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation or flutter
3. The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
4. 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
5. The patient is deemed suitable for LAA closure in a shared decision model with a non-implanting physician
6. The patient is willing and able to comply with protocol-specified treatment and follow-up evaluations
7. 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:
2. The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation or flutter
3. The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
4. 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
5. The patient is deemed suitable for LAA closure in a shared decision model with a non-implanting physician
6. The patient is willing and able to comply with protocol-specified treatment and follow-up evaluations
7. 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:
Exclusion Criteria
1. 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
2. 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)
3. Patients who require long-term anticoagulation/DAPT for a condition other than atrial fibrillation
4. 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
5. Patients with rheumatic mitral valve disease, known severe aortic stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis
6. Active infection with bacteremia
7. 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
8. 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)
9. 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.)
10. Recent (within 90 days pre-procedure) stroke, transient ischemic attack, or myocardial infarction
11. Severe heart failure (New York Heart Association Class IV)
12. 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%.
13. Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant
14. Current participation in another investigational drug or device study
15. Size of the left atrial appendage at the LAmbre Plus defined landing zone within outside the manufactures recommendations (Table 2.)
16. Patients with an indication for chronic P2Y12 platelet inhibition therapy
17. Patients who are unable to undergo CT scan
1. Left atrial appendage anatomy may accommodate implantation of the WATCHMAN device, according to IFU by size.
2. LVEF \<25%
3. Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
4. Presence of a high-risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \>15 mm) or large shunt (early, within 3 beats and/or substantial passage of bubbles)
5. Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
6. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch (Grade 4 or higher)
7. Presence of an intracardiac tumor
2. 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)
3. Patients who require long-term anticoagulation/DAPT for a condition other than atrial fibrillation
4. 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
5. Patients with rheumatic mitral valve disease, known severe aortic stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis
6. Active infection with bacteremia
7. 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
8. 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)
9. 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.)
10. Recent (within 90 days pre-procedure) stroke, transient ischemic attack, or myocardial infarction
11. Severe heart failure (New York Heart Association Class IV)
12. 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%.
13. Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant
14. Current participation in another investigational drug or device study
15. Size of the left atrial appendage at the LAmbre Plus defined landing zone within outside the manufactures recommendations (Table 2.)
16. Patients with an indication for chronic P2Y12 platelet inhibition therapy
17. Patients who are unable to undergo CT scan
1. Left atrial appendage anatomy may accommodate implantation of the WATCHMAN device, according to IFU by size.
2. LVEF \<25%
3. Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
4. Presence of a high-risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \>15 mm) or large shunt (early, within 3 beats and/or substantial passage of bubbles)
5. Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
6. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch (Grade 4 or higher)
7. Presence of an intracardiac tumor
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
Brian O'Neill MD
OTHER
Sponsor Role
lead
Responsible Party
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Brian O'Neill MD
Director of Interventional Cardiology Research
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Brian O'Neill, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Henry Ford Hospital
Detroit, Michigan, United States
Site Status
Countries
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United States
References
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VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
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Sahay S, Nombela-Franco L, Rodes-Cabau J, Jimenez-Quevedo P, Salinas P, Biagioni C, Nunez-Gil I, Gonzalo N, de Agustin JA, Del Trigo M, Perez de Isla L, Fernandez-Ortiz A, Escaned J, Macaya C. Efficacy and safety of left atrial appendage closure versus medical treatment in atrial fibrillation: a network meta-analysis from randomised trials. Heart. 2017 Jan 15;103(2):139-147. doi: 10.1136/heartjnl-2016-309782. Epub 2016 Sep 1.
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Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
G-200316
Identifier Type: -
Identifier Source: org_study_id
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