FIM Study of the LAmbreâ„¢ II LAA Occluder in Non-Valvular AF Patients (NCT07385599) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
FIM Study of the LAmbreâ„¢ II LAA Occluder in Non-Valvular AF Patients
Hong Kong10 participantsStarted 2026-01-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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);
What they're measuring
1
The primary effective endpoint is closure success
Timeframe: 12 months post-procedure.
2
The primary safety endpoint is major peri-procedural complications
Timeframe: Within 7 days following the implant procedure or by hospital discharge
. 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;