LAmbre II Left Atrial Appendage Occluder in non-valvular AF patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the preliminary safety and feasibility of the LAmbre II Left Atrial Appendage Occluder and its delivery system in adults with non-valvular atrial fibrillation who are at increased stroke risk and for whom non-pharmacologic stroke prevention is considered. Participants must be 18 years or older, have NVAF with a CHA2DS2-VASc score indicating elevated risk, and be suitable for LAA closure as part of shared decision-making. The study will document procedural outcomes and short-term follow-up to determine if the device can be used safely and effectively as an alternative to oral anticoagulation in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient age ≥18 years;
2. The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;
3. The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;
4. The patient is recommended for oral anticoagulation therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation;
5. 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;
6. The patient is willing and able to comply with the required medication post-procedure and follow-up evaluations;
7. 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:

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;
2. 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);
3. Patients who require long-term anticoagulation for a condition other than atrial fibrillation;
4. Bleeding diathesis or coagulopathy;
5. Patients with rheumatic mitral valve disease, known severe mitral stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis;
6. Active infection with bacteremia;
7. Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, any device material or component (nickel titanium, PET, polypropylene), and/or contrast sensitivity;
8. Prior atrial septal defect (ASD) or patient foramen ovale (PFO) surgical repair or implantation of closure device;
9. Left atrial appendage is obliterated and surgical ligated;
10. 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.);
11. Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;
12. New York Heart Association Class IV;
13. Patients with severe renal failure (estimated glomerular filtration rate\<30 ml/min/1.73m2);
14. 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%;
15. Life expectancy is less than 1 year;
16. Current participation in another investigational drug or device study.

Where it's running

• Prince of Wales Hospital, Chinese University of Hong Kong, HKSAR
  Shatin, Hong Kong Recruiting

Study contacts

• Principal investigator: Kent CY So, Professor — Prince of Wales Hospital, Chinese University of Hong Kong, HKSAR
• Study coordinator: Kent CY So, Professor
• Email: Scy309@ha.org.hk
• Phone: 0852-3505-1518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.