FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients

NCT07385599 | Active Not Recruiting

• 1 other identifier: LT-TS-154-2025-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Keywords

Lifetech; FIM study; LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System; LAmbre™ II; LAmbre™ II Left Atrial Appendage Occluder; Left Atrial Appendage Occluder; LAmbre™ II LAAO

Outcome Measures

Primary Outcomes (2)

• The primary effective endpoint is closure success

  Defined as complete LAA closure or peri-device residual leak ≤ 3 mm measured by TEE.

  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.

  Within 7 days following the implant procedure or by hospital discharge

Secondary Outcomes (11)

• Major adverse events

  Evaluated within 7 days following the implant procedure or by hospital discharge and 30 days and 3, 6, 12 months post-procedure

• Closure success

  Evaluated at 30 days and 3, 6 months post-procedure

• Rate of bleeding complications

  Evaluated within 7 days following the implant procedure or by hospital discharge, 30 days and 3, 6, 12 months post-procedure

• Cardiovascular death

  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

  Evaluated within 7 days following the implant procedure or by hospital discharge, 30 days and 3, 6, 12 months post-procedure

Study Arms (1)

LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System

EXPERIMENTAL

Device: LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System

Interventions

LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System DEVICE

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.

LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong, HKSAR

Shatin, Hong Kong

Location

Study Officials

• Kent CY So, Professor

  Prince of Wales Hospital, Chinese University of Hong Kong, HKSAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: February 4, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

HK (1)