An interventional study of LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System in Non-valvular Atrial Fibrillation (NVAF), sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Not applicable, Interventional, and Other
To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.
Worldwide, atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. The prevalence of AF gradually increases with age; its prevalence is 0.5% \~ 0.8% among 45 \~ 59 year-olds, 1.8% \~ 5.9% among 60 \~ 69 year-olds, and 6.7% \~ 17.9% among > 79 year-olds. Thromboembolic complications are the leading cause of death and disability in patients with AF, with ischemic stroke being the most common complication. AF significantly increases the risk of stroke by 3- to 5-fold due to thrombosis caused by abnormal atrial beat. The overall risk of ischemic stroke in patients with AF is 20% \~ 30%, and strokes due to atrial fibrillation account for 20% of all strokes.
Oral anticoagulation (OAC) is the standard of care in the management of non-valvular atrial fibrillation for stroke prevention and is recommended in the USA and European guidelines. However, the use of warfarin, a traditional oral anticoagulant, requires frequent and careful monitoring to ensure adequate anticoagulation as well as to prevent over-anticoagulation. This necessitates frequent laboratory blood tests to maintain the International Normalization Ratio (INR), a measure of the efficacy of the warfarin regimen, which can lead to patient non-adherence. Sub-therapeutic INR does not prevent systemic embolization, and supratherapeutic INR is a risk for haemorrhage. Moreover, the impact of interactions with other drugs, diet, narrow therapeutic window, and other reasons limit the use of warfarin. Several studies have shown that in clinical practice anticoagulation is given to less than 50% \~ 60% of patients with indications and discontinuation rates of warfarin approach 33% per year. Non-vitamin K antagonist oral anticoagulants (NOAC) have been shown to have a non-inferiority or superior effect in stroke reduction compared to warfarin without the need for routine laboratory monitoring. However, due to the high cost of NOACs and the lack of stable and effective antagonists, treatment discontinuation rates of up to 20% have been reported, and there is still an absolute risk of bleeding of 2% to 3% per year. A safe and effective alternative to anticoagulation for the stroke prevention in AF is needed, as the bleeding risk of anticoagulation and the presence of patient refusal/non-adherence/intolerance to long-term anticoagulation.
For a majority of patients with atrial fibrillation, it appears that thrombus formation would be located in the Left atrial appendage (LAA). Previous studies have suggested that more than 90% of thrombi in patients with non-valvular atrial fibrillation (NVAF) are located in the LAA. Therefore, surgical and percutaneous techniques to occlude the LAA could be a solution to reduce the risk of ischemic stroke for patients with AF. Surgical ligation of the LAA during the mitral valve surgery can reduce the risk of stroke, however, it is difficult to completely close the LAA by surgical ligation. Studies evaluating the incidence of incomplete ligation of the LAA during mitral valve surgery have shown that TEE-detected incidence of incomplete LAA ligation is about 36%. The WATCHMAN device (Boston Scientific, Natick, Massachusetts) is the most studied percutaneous left atrial appendage closure (LAAC) device and has shown that safety and efficacy are non-inferior to warfarin. In the current 2023 ACC/AHA/ACCP/HRS Guideline, percutaneous LAAC has been classified as a Class 2a indication for stroke prevention in patients with AF, a moderate to high risk of stroke, and a contraindication to long-term oral anticoagulation due to a non-reversible cause. However, the implantation procedure does have adverse effects which include serious pericardial effusion, procedure-related ischemic stroke, and device embolization. Due to the anatomical diversity of the LAA, certain patients are not candidates for this device.
The LAmbre™ Left Atrial Appendage Closure System, manufactured by Lifetech Scientific (Shenzhen) Co. Ltd., is the first generation of LAmbre LAAO device which is CE-marked and is current approved in Hong Kong Hospital Authority for regular clinical use. It consists of a LAA Occluder and a Delivery System and is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage in patients who have nonvalvular atrial fibrillation. This self-expanding LAA Occluder consists of an umbrella and a cover connected by a central waist. Although the first generation of LAmbre LAAO device is associated with high implantation success rate of 99.7% and a relatively low major procedure-related complication rate of 2.9%, to better match the challenging anatomy of the LAA and to further improve procedural safety, the first generation of LAmbre LAA O device has been upgraded.
The LAmbre™ II Left Atrial Appendage Occluder is the second generation of LAmbre LAAO device which is used with the Occluder Delivery System to seal off the left atrial appendage to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have non-valvular atrial fibrillation. As an upgraded version of the LAmbre™ Left Atrial Appendage Occluder, the LAmbre™ II Left Atrial Appendage Occluder has a number of modifications including: the connection of Umbrella and Cover has been changed from the welded connection to the snap connection, which allows the Umbrella and Cover to be freely combined; the PET Membrane of the Cover has been added with a PC coating; the shape of the Cover has been changed from conical shape to disc shape; the structure of the end of U-shaped hook has been changed from a single beam structure to a diamond shape structure; the material of the Cover changed from 72 NiTi wires to 144 NiTi wires This study is a first-in-man study aimed at preliminary assessing the safety and feasibility of the LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System. The results of this study will be the basis for the design of subsequent confirmatory studies.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 10 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System
To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.
The primary effective endpoint is closure success
Defined as complete LAA closure or peri-device residual leak ≤ 3 mm measured by TEE.
Time frame: 12 months post-procedure.
The primary safety endpoint is major peri-procedural complications
Including cardiac perforation, pericardial effusion with tamponade or requiring drainage, device embolization, death, ischemic stroke, systemic embolism, and major vascular complications occurring within 7 days following the implant procedure or by hospital discharge, whichever is later.
Time frame: Within 7 days following the implant procedure or by hospital discharge
Major adverse events
Defined as death, stroke, systemic embolism, pericardial effusion with tamponade or requiring drainage, device embolization, and major bleeding (BARC defined 3 or 5)
Time frame: Evaluated within 7 days following the implant procedure or by hospital discharge and 30 days and 3, 6, 12 months post-procedure
Closure success
Assessed by TEE or cardiac computed tomography
Time frame: Evaluated at 30 days and 3, 6 months post-procedure
Rate of bleeding complications
Evaluated as major bleeding (BARC Type 3 or 5) and minor bleeding (BARC type 2)
Time frame: Evaluated within 7 days following the implant procedure or by hospital discharge, 30 days and 3, 6, 12 months post-procedure
Cardiovascular death
(cardiovascular and/or unexplained cause)
Time frame: Evaluated within 7 days following the implant procedure or by hospital discharge, 30 days and 3, 6, 12 months post-procedure
Rate of ischemic stroke and systemic embolization
Time frame: Evaluated within 7 days following the implant procedure or by hospital discharge, 30 days and 3, 6, 12 months post-procedure
Technical success rate
Defined as successful delivery and release of study device with acceptable device position and stability, and closure success
Time frame: Evaluated immediately after the procedure
Procedural success rate
Defined as technical success without major peri-procedural complications
Time frame: Evaluated at 7 days following the implant procedure or by hospital discharge, whichever comes later
Device-related thrombosis
Defined as the detection of thrombus adherent to the left atrial side of the device by TEE or cardiac computed tomography
Time frame: Evaluated at 30 days and 3, 6, 12 months post-procedure
Occluder Delivery System related complication
Time frame: Evaluated immediately after the procedure and within 7 days following the implant procedure or by hospital discharge
Performance Assessment of the Occluder Delivery System
Including accuracy, flexibility, pushability, withdrawal of delivery system (Grade I-V, V represents the best).
Time frame: Evaluated during the procedure
Performance Assessment of the Occluder Delivery System: Puncture success
Defined as the successful puncture of the oval fossa region of the interatrial septum under fluoroscopy or TEE guidance, without changing the puncture needle or puncture site. The delivery sheath and dilator are then successfully advanced into the left atrium.
Time frame: Evaluated during the procedure
Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 23 months is close to that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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