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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System
DeviceTo 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The primary effective endpoint is closure success
Defined as complete LAA closure or peri-device residual leak ≤ 3 mm measured by TEE.
Time frame
12 months post-procedure.2
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.
Time frame
Within 7 days following the implant procedure or by hospital dischargeSecondary outcomes
1
Major adverse events
Defined as death, stroke, systemic embolism, pericardial effusion with tamponade or requiring drainage, device embolization, and major bleeding (BARC defined 3 or 5)
Time frame
Evaluated within 7 days following the implant procedure or by hospital discharge and 30 days and 3, 6, 12 months post-procedure2
Closure success
Assessed by TEE or cardiac computed tomography
Time frame
Evaluated at 30 days and 3, 6 months post-procedure3
Rate of bleeding complications
Evaluated as major bleeding (BARC Type 3 or 5) and minor bleeding (BARC type 2)
Time frame
Evaluated within 7 days following the implant procedure or by hospital discharge, 30 days and 3, 6, 12 months post-procedure4
Cardiovascular death
(cardiovascular and/or unexplained cause)
Time frame
Evaluated within 7 days following the implant procedure or by hospital discharge, 30 days and 3, 6, 12 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov