Non Valvular Atrial FibrillationLAmbre2NCT07455539
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
A study testing LAmbre II Left Atrial Appendage Occluder in people with Non Valvular Atrial Fibrillation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Valvular Atrial Fibrillation
- What is being tested?
- LAmbre II Left Atrial Appendage Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Mar 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The patient age ≥18 years;
- The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;
- The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;
- The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation;
- The patient is deemed suitable for LAA closure by the site investigator and a clinician not a part of the procedural team in the shared decision-making process, and this determination has been documented in the patient's medical record;
- The patient is willing and able to comply with the required medication post-procedure 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).
Who cannot join
- 1. Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to the index procedure;
- 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 for a condition other than atrial fibrillation;
- Bleeding diathesis or coagulopathy;
- Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis;
- Active infection with bacteremia;
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- Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and/or contrast sensitivity;
- Prior atrial septal defect (ASD) or patient foramen ovale (PFO) surgical repair or implantation of closure device;
- Left atrial appendage is obliterated and surgical ligated;
- Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, cataract surgery, etc.);
- Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;
- New York Heart Association Class IV;
- Patients with severe renal failure (estimated glomerular filtration rate<30 ml/min/1.73m2);
- 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%;
- Life expectancy is less than 1 year;
- Current participation in another investigational drug or device study.
- Echocardiographic Exclusion Criteria:
- Left atrial appendage anatomy cannot accommodate the LAmbre II LAA Occluder per manufacturer IFU;
- LVEF <30%;
- Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE prior to implant;
- 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 20 bubbles);
- Existing circumferential pericardial effusion >5 mm;
- Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2);
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch;
- Presence of a cardiac tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Man (FIM) Study of the LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
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.
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 nonreversible 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.
Read more
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 LAAO device has been upgraded.
The LAmbre™ II Left Atrial Appendage Occluder, designed to prevent thrombus embolization and reduce the risk of bleeding events in patients with non-valvular atrial fibrillation, is being evaluated in a prospective, single-center, single-arm First In Man (FIM) study. The study, conducted at the Prince of Wales Hospital, Chinese University of Hong Kong, aims to assess the preliminary safety and feasibility of the device and its Occluder Delivery System in 10 subjects who are at increased risk for stroke and systemic embolism, either due to their anticoagulation therapy eligibility or contraindications.
The enrollment period is expected to take approximately 6 months and subjects will have follow-up before discharge and at 30 days, 3M, 6M, 12M months post-operation. The total study duration is expected to be approximately 19 months.
- Conditions
- Non Valvular Atrial Fibrillation
- Being tested
- LAmbre II Left Atrial Appendage Occluder
- Keywords
- non valvular atrial fibrillation, Left Atrial Appendage, Left Atrial Appendage Occluder, Left Atrial Appendage Occlusion, Stroke prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAmbre II Left Atrial Appendage OccluderDevice
The LAmbre™ II Left Atrial Appendage Occluder, designed to prevent thrombus embolization and reduce the risk of bleeding events in patients with non-valvular atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: LAmbre II Left Atrial Appendage Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
LAA closure success rate
complete LAA closure or peri-device residual leak ≤3 mm measured by TEE at 3 months post-procedure
Measured: 3 months post-procedure
Procedural complication rate
Rate of complication rate peri-procedure
Measured: peri-procedure
Secondary outcomes (68)
Rate of death
Rate of death at discharge
Measured: Perioperative
Rate of stroke
Rate of stroke at discharge
Measured: Perioperative
Rate of stroke
Rate of stroke at 30 days post-OP
Measured: At 30 days post-OP
Rate of stroke
Rate of stroke at 6 months post-OP
Measured: At 6 months post-OP
Rate of stroke
Rate of stroke at 12 months post-OP
Measured: At 12 months post-OP
Rate of systemic embolism
Rate of systemic embolism at discharge
Measured: Perioperative
Rate of systemic embolism
Rate of systemic embolism at 30 days post-OP
Measured: At 30 days post-OP
Rate of systemic embolism
Rate of systemic embolism at 3 months post-OP
Measured: At 3 months post-OP
Rate of systemic embolism
Rate of systemic embolism at 6 months post-OP
Measured: At 6 months post-OP
Rate of systemic embolism
Rate of systemic embolism at 12 months post-OP
Measured: At 12 months post-OP
Rate of pericardial effusion with tamponade
Rate of pericardial effusion with tamponade at discharge
Measured: Perioperative
Rate of pericardial effusion with tamponade
Rate of pericardial effusion with tamponade at 30 days post-OP
Measured: At 30 days post-OP
Rate of pericardial effusion with tamponade
Rate of pericardial effusion with tamponade at 3 months post-OP
Measured: At 3 months post-OP
Rate of pericardial effusion with tamponade
Rate of pericardial effusion with tamponade at 6 months post-OP
Measured: At 6 months post-OP
Rate of pericardial effusion with tamponade
Rate of pericardial effusion with tamponade at 12 months post-OP
Measured: At 12 months post-OP
Rate of pericardial effusion requiring drainage
Rate of pericardial effusion requiring drainage at discharge
Measured: Perioperative
Rate of pericardial effusion requiring drainage
Rate of pericardial effusion requiring drainage at 30 days post-OP
Measured: At 30 days post-OP
Rate of pericardial effusion requiring drainage
Rate of pericardial effusion requiring drainage at 3 months post-OP
Measured: At 3 months post-OP
Rate of pericardial effusion requiring drainage
Rate of pericardial effusion requiring drainage at 6 months post-OP
Measured: At 6 months post-OP
Rate of pericardial effusion requiring drainage
Rate of pericardial effusion requiring drainage at 12 months post-OP
Measured: At 12 months post-OP
Rate of device embolization
Rate of device embolization at discharge
Measured: Perioperative
Rate of device embolization
Rate of device embolization at discharge at 30 days post-OP
Measured: At 30 days post-OP
Rate of device embolization
Rate of device embolization at 3 months post-OP
Measured: At 3 months post-OP
Rate of death
Rate of death at 30 days
Measured: At 30 days
Rate of death
Rate of death at 3 months post-OP
Measured: At 3 months post-OP
Rate of death
Rate of death at 6 months post-OP
Measured: At 6 months post-OP
Rate of death
Rate of death at 12 months post-OP
Measured: At 12 months post-OP
Rate of device embolization
Rate of device embolization at 6 months post-OP
Measured: At 6 months post-OP
Rate of device embolization
Rate of device embolization at 12 months post-OP
Measured: At 12 months post-OP
Rate of major bleeding (BARC defined 3 to 5)
Rate of major bleeding (BARC defined 3 to 5) at discharge
Measured: Perioperative
Rate of major bleeding (BARC defined 3 to 5)
Rate of major bleeding (BARC defined 3 to 5) at 30 days post-OP
Measured: At 30 days post-OP
Rate of major bleeding (BARC defined 3 to 5)
Rate of major bleeding (BARC defined 3 to 5) at 3 months post-OP
Measured: At 3 months post-OP
Rate of major bleeding (BARC defined 3 to 5)
Rate of major bleeding (BARC defined 3 to 5) at 6 months post-OP
Measured: At 6 months post-OP
Rate of major bleeding (BARC defined 3 to 5)
Rate of major bleeding (BARC defined 3 to 5) at 12 months post-OP
Measured: At 12 months post-OP
Closure success assessed by TEE or cardiac computed tomography
Closure success assessed by TEE or cardiac computed tomography at 30 days post-procedure
Measured: At 30 days post-procedure
Closure success assessed by TEE or cardiac computed tomography
Closure success assessed by TEE or cardiac computed tomography at 6 months post-procedure
Measured: At 6 months post-procedure
Closure success assessed by TEE or cardiac computed tomography
Closure success assessed by TEE or cardiac computed tomography at 12 months post-procedure
Measured: At 12 months post-procedure
Rate of minor bleeding (BARC type 2)
Rate of minor bleeding (BARC type 2) at discharge
Measured: At discharge, 30 days and 3, 6, 12 months post-procedure
Rate of minor bleeding (BARC type 2)
Rate of minor bleeding (BARC type 2) at 30 days post-procedure
Measured: At 30 days post-procedure
Rate of minor bleeding (BARC type 2)
Rate of minor bleeding (BARC type 2) at 3 months post-procedure
Measured: At 3 months post-procedure
Rate of minor bleeding (BARC type 2)
Rate of minor bleeding (BARC type 2) at 6 months post-procedure
Measured: At 6 months post-procedure
Rate of minor bleeding (BARC type 2)
Rate of minor bleeding (BARC type 2) at 12 months post-procedure
Measured: At 12 months post-procedure
Rate of cardiovascular death
Rate of cardiovascular death at discharge
Measured: Perioperative
Rate of cardiovascular death
Rate of cardiovascular death at 30 days post-procedure.
Measured: At 30 days post-procedure
Rate of cardiovascular death
Rate of cardiovascular death at 3 months post-procedure.
Measured: At 3 months post-procedure
Rate of cardiovascular death
Rate of cardiovascular death at 6 months post-procedure.
Measured: At 6 months post-procedure
Rate of cardiovascular death
Rate of cardiovascular death at 12 months post-procedure.
Measured: At 12 months post-procedure
Rate of ischemic stroke
Rate of ischemic stroke at discharge
Measured: Perioperative
Rate of ischemic stroke
Rate of ischemic stroke at 30 days post-procedure
Measured: At 30 days post-procedure
Rate of ischemic stroke
Rate of ischemic stroke at 3 months post-procedure
Measured: At 3 months post-procedure
Rate of ischemic stroke
Rate of ischemic stroke at 6 months post-procedure
Measured: At 6 months post-procedure
Rate of ischemic stroke
Rate of ischemic stroke at 12 months post-procedure
Measured: At 12 months post-procedure
Rate of hemorrhagic stroke
Rate of hemorrhagic stroke at discharge
Measured: Perioperative
Rate of hemorrhagic stroke
Rate of hemorrhagic stroke at 30 days post-procedure
Measured: At 30 days post-procedure
Rate of hemorrhagic stroke
Rate of hemorrhagic stroke at 3 months post-procedure
Measured: At 3 months post-procedure
Rate of hemorrhagic stroke
Rate of hemorrhagic stroke at 6 months post-procedure
Measured: At 6 months post-procedure
Rate of hemorrhagic stroke
Rate of hemorrhagic stroke at 12 months post-procedure
Measured: At 12 months post-procedure
Rate of systemic embolization
Rate of systemic embolization at discharge
Measured: Perioperative
Rate of systemic embolization
Rate of systemic embolization at 30 days post-procedure
Measured: At 30 days post-procedure
Rate of systemic embolization
Rate of systemic embolization at 3 months post-procedure
Measured: At 3 months post-procedure
Rate of systemic embolization
Rate of systemic embolization at 6 months post-procedure
Measured: At 6 months post-procedure
Rate of systemic embolization
Rate of systemic embolization at 12 months post-procedure
Measured: At 12 months post-procedure
Procedural Technical success rate
Procedural Technical success rate, defined as successful delivery and release of study device with acceptable device position and stability, and closure success;
Measured: During procedure
Procedural success rate
Procedural success rate, defined as technical success without major peri-procedural complications
Measured: Peri-procedure
Rate of Device-related thrombosis
Rate of Device-related thrombosis, defined as the detection of thrombus adherent to the left atrial side of the device by TEE or cardiac computed tomography at 30 days post-procedure
Measured: At 30 days post-procedure
Rate of Device-related thrombosis
Rate of Device-related thrombosis, defined as the detection of thrombus adherent to the left atrial side of the device by TEE or cardiac computed tomography at 3 months post-procedure
Measured: At 3 months post-procedure
Rate of Device-related thrombosis
Rate of Device-related thrombosis, defined as the detection of thrombus adherent to the left atrial side of the device by TEE or cardiac computed tomography at 6 months post-procedure
Measured: At 6 months post-procedure
Rate of Device-related thrombosis
Rate of Device-related thrombosis, defined as the detection of thrombus adherent to the left atrial side of the device by TEE or cardiac computed tomography at 12 months post-procedure
Measured: At 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start5 Mar 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 May 2028 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455539
- Sponsor's protocol ID
- 2025.451
- Acronym
- LAmbre2
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Man (FIM) Study of the LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07455539
- Acronym / sponsor ID
- LAmbre2 / 2025.451
- Conditions
- Non Valvular Atrial Fibrillation
- Keywords
- non valvular atrial fibrillation, Left Atrial Appendage, Left Atrial Appendage Occluder, Left Atrial Appendage Occlusion, Stroke prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 6 Mar 2026 (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.
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.
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 nonreversible 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 LAAO device has been upgraded.
The LAmbre™ II Left Atrial Appendage Occluder, designed to prevent thrombus embolization and reduce the risk of bleeding events in patients with non-valvular atrial fibrillation, is being evaluated in a prospective, single-center, single-arm First In Man (FIM) study. The study, conducted at the Prince of Wales Hospital, Chinese University of Hong Kong, aims to assess the preliminary safety and feasibility of the device and its Occluder Delivery System in 10 subjects who are at increased risk for stroke and systemic embolism, either due to their anticoagulation therapy eligibility or contraindications.
The enrollment period is expected to take approximately 6 months and subjects will have follow-up before discharge and at 30 days, 3M, 6M, 12M months post-operation. The total study duration is expected to be approximately 19 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: LAmbre II Left Atrial Appendage Occluder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient age ≥18 years;
- The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;
- The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;
- The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation;
- The patient is deemed suitable for LAA closure by the site investigator and a clinician not a part of the procedural team in the shared decision-making process, and this determination has been documented in the patient's medical record;
Key exclusion criteria (25 listed)
- 1. Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to the index procedure;
- 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 for a condition other than atrial fibrillation;
- Bleeding diathesis or coagulopathy;
- Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis;
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 |
|---|---|---|
| LAmbre II Left Atrial Appendage OccluderThe LAmbre™ II Left Atrial Appendage Occluder, designed to prevent thrombus embolization and reduce the risk of bleeding events in patients with non-valvular atrial fibrillation | Device | Intervention |
Primary outcome
LAA closure success rate
Time frame: 3 months post-procedure
complete LAA closure or peri-device residual leak ≤3 mm measured by TEE at 3 months post-procedure
Procedural complication rate
Time frame: peri-procedure
Rate of complication rate peri-procedure
68 secondary outcomes
Rate of death
Time frame: Perioperative
Rate of stroke
Time frame: Perioperative
Rate of stroke
Time frame: At 30 days post-OP
Rate of stroke
Time frame: At 6 months post-OP
Rate of stroke
Time frame: At 12 months post-OP
Rate of systemic embolism
Time frame: Perioperative
Rate of systemic embolism
Time frame: At 30 days post-OP
Rate of systemic embolism
Time frame: At 3 months post-OP
Rate of systemic embolism
Time frame: At 6 months post-OP
Rate of systemic embolism
Time frame: At 12 months post-OP
Rate of pericardial effusion with tamponade
Time frame: Perioperative
Rate of pericardial effusion with tamponade
Time frame: At 30 days post-OP
Rate of pericardial effusion with tamponade
Time frame: At 3 months post-OP
Rate of pericardial effusion with tamponade
Time frame: At 6 months post-OP
Rate of pericardial effusion with tamponade
Time frame: At 12 months post-OP
Rate of pericardial effusion requiring drainage
Time frame: Perioperative
Rate of pericardial effusion requiring drainage
Time frame: At 30 days post-OP
Rate of pericardial effusion requiring drainage
Time frame: At 3 months post-OP
Rate of pericardial effusion requiring drainage
Time frame: At 6 months post-OP
Rate of pericardial effusion requiring drainage
Time frame: At 12 months post-OP
Rate of device embolization
Time frame: Perioperative
Rate of device embolization
Time frame: At 30 days post-OP
Rate of device embolization
Time frame: At 3 months post-OP
Rate of death
Time frame: At 30 days
Rate of death
Time frame: At 3 months post-OP
Rate of death
Time frame: At 6 months post-OP
Rate of death
Time frame: At 12 months post-OP
Rate of device embolization
Time frame: At 6 months post-OP
Rate of device embolization
Time frame: At 12 months post-OP
Rate of major bleeding (BARC defined 3 to 5)
Time frame: Perioperative
Rate of major bleeding (BARC defined 3 to 5)
Time frame: At 30 days post-OP
Rate of major bleeding (BARC defined 3 to 5)
Time frame: At 3 months post-OP
Rate of major bleeding (BARC defined 3 to 5)
Time frame: At 6 months post-OP
Rate of major bleeding (BARC defined 3 to 5)
Time frame: At 12 months post-OP
Closure success assessed by TEE or cardiac computed tomography
Time frame: At 30 days post-procedure
Closure success assessed by TEE or cardiac computed tomography
Time frame: At 6 months post-procedure
Closure success assessed by TEE or cardiac computed tomography
Time frame: At 12 months post-procedure
Rate of minor bleeding (BARC type 2)
Time frame: At discharge, 30 days and 3, 6, 12 months post-procedure
Rate of minor bleeding (BARC type 2)
Time frame: At 30 days post-procedure
Rate of minor bleeding (BARC type 2)
Time frame: At 3 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAmbre II Left Atrial Appendage Occluder in people with Non Valvular Atrial Fibrillation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
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?
LAA closure success rate (time frame: 3 months post-procedure). The study lists 2 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 18 Sep 2026.