FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov