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NCT07455539: LAmbre2
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
NA trial testing LAmbre II Left Atrial Appendage Occluder in Non Valvular Atrial Fibrillation in 10 participants. Not yet recruiting.
1 November 2027
Quick facts
| Lead sponsor | Prince of Wales Hospital, Shatin, Hong Kong |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 April 2026 |
| Primary completion | 1 November 2027 |
| Estimated completion | 1 May 2028 |
Drugs / interventions tested
- LAmbre II Left Atrial Appendage Occluder
Conditions studied
- Non Valvular Atrial Fibrillation — all drugs for Non Valvular Atrial Fibrillation →
Sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Who can join
18 and older, any sex, with Non Valvular Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07455539 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prince of Wales Hospital, Shatin, Hong Kong
- Last refreshed: 6 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07455539.
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