A Prospective, Multicenter, Randomized Controlled Trial Assessing the Safety and Efficacy of the LAmbre™ Plus Left Atrial Appendage Closure System to REDUCE the Risk of Thromboembolism in Patients With Non-Valvular Atrial Fibrillation
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- Kansas City Heart Rhythm Research Foundation
- 入组人数
- 1826
- 主要终点
- Major adverse event - all strokes
- 状态
- 尚未招募
- 最后更新
- 去年
概览
简要总结
Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.
详细描述
The goal of this clinical trial is to demonstrate the safety and efficacy of the LAmbre Plus device in patients with non-valvular atrial fibrillation in comparison with the commercially available transcatheter LAAO device(s). The main questions it aims to answer are: Overall safety of the device that is assessed at the 12 month time period. Overall efficacy, after all subjects have reached the 18 month time period. Participants will be randomized to either the LAmbre device or other FDA approved LAAO devices.
研究者
入排标准
入选标准
- •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
- •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 warfarin 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 a multidisciplinary heart team, including at least 1 investigator (e.g. cardiologists) and 1 clinician not involved as part of the procedure team using a 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 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)
排除标准
- •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)
- •Patients who require long-term anticoagulation for a condition other than atrial fibrillation
- •Patients with an indication for chronic P2Y12 platelet inhibition therapy
- •Patients not suitable for short term warfarin (including due to bleeding diathesis or coagulopathy or absolute contraindication warfarin) 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)
- •Recent (within 30 days pre-procedure) or planned (within 60 days post- procedure) cardiac or non-cardiac interventional or surgical procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, cataract surgery, etc.)
结局指标
主要结局
Major adverse event - all strokes
时间窗: up to 7 days following implant procedure
Stroke is identified by neurologic imaging and transient or permanent motor or sensory deficient.
Major adverse event - major bleeding
时间窗: up to 7 days following implant procedure
Visual bleeding or a drop in hemoglobin of 2 units and requiring transfusion.
Major procedure related complications - cardiac perforation
时间窗: up to 7 days following implant procedure
Cardiac perforation can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Major adverse event - systemic embolization
时间窗: up to 7 days following implant procedure
Systemic embolization assessed by onsite symptoms and confirmed by diagnostic imaging.
Major procedure related complications - pericardial effusion with tamponade or requiring drainage
时间窗: up to 7 days following implant procedure
Common complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Major procedure related complications - device embolization
时间窗: up to 7 days following implant procedure
Procedure complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Major adverse event - Death
时间窗: up to 7 days following implant procedure
Death is observed by lack of oxygen, lack of pulse, succession of neurological activity.
次要结局
- myocardial infarction(45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years)
- Major adverse event(45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years)
- mortality(45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years)
- periprocedural stroke(45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years)
- bleeding complications(45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years)
- major procedure-related complications(45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years)
- vascular complications(45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years)