Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF (NCT04684212) | Clinical Trial Compass
WithdrawnNot Applicable
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF
Stopped: Lack of Funding
United States0Started 2024-06-01
Plain-language summary
The primary objective is to demonstrate the safety and efficacy of the implantation of the LAmbre PlusTM device in patients with large or irregularly shaped appendages with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism compared to oral anticoagulation (OAC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient is a male or non-pregnant female ≥18 years of age
✓. The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation or flutter
✓. The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
✓. The patient is deemed by their physician to be suitable for short-term OAC, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation
✓. The patient is deemed suitable for LAA closure in a shared decision model with a non-implanting physician
✓. The patient is willing and able to comply with protocol-specified treatment 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 in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test
✕. 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
Composite of time to first occurrence of stroke, cardiovascular death, or clinically relevant major or non-major bleeding events
Timeframe: through study completion, up to 5 years
2
Composite of time to first occurrence of ischemic stroke or systemic embolism
Timeframe: through study completion, up to of 5 years
. Patients who require long-term anticoagulation/DAPT for a condition other than atrial fibrillation
✕. Patients not suitable for short term oral anti-coagulation (including due to bleeding diathesis or coagulopathy or absolute contraindication to OAC or DAPT ) or who will refuse transfusion
✕. Patients with rheumatic mitral valve disease, known severe aortic stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis
✕. Active infection with bacteremia
✕. Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin/bivalirudin, any device material or component (nitinol, nickel, titanium, PET), and/or contrast sensitivity that cannot be adequately pre-medicated
✕. Anatomic conditions that would prevent performance of the LAA occlusion procedure (e.g., prior atrial septal defect \[ASD\] or patient foramen ovale \[PFO\] surgical repair or implanted closure device, or obliterated left atrial appendage)