Prospective, Single-arm Study to Assess the Safety and Performance of the Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 26
- 主要终点
- LAA (Left Atrial Appendage) closure
研究概览
简要总结
The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk.
详细描述
Omega™ LAA (Left Atrial Appendage) Occluder used in combination with the indicated Omega™ Delivery System is a permanent implant to the left atrial appendage for percutaneous insertion. LLA (Left Atrial Appendage) occlusion appears to be a feasible option for stroke reduction in AF patients at high risk for stroke, who are contraindicated for anticoagulation or who suffered a stroke despite OC. This study will evaluate safety and performance, using a study design which is based on inputs from pre-clinical testing, the risk analysis and data available from other LAA (Left Atrial Appendage) devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
- •At increased risk of stroke or systemic embolism defined as a CHA2DS2-VASc score > or = 2
- •To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device
- •Able and willing to comply with the required medication regimen post-device implant
- •Able to understand and willing to provide written informed consent to participate in the study
排除标准
- •Requires long-term oral anticoagulation therapy for any indication other than atrial fibrillation
- •Contraindicated for or allergic to aspirin, clopidogrel, warfarin or novel oral anticoagulant (NOAC) use
- •Has any contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transoesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
- •Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure
- •Myocardial infarction (MI) within 90 days prior to implant
- •New York Heart Association Class IV Congestive Heart Failure
- •Left ventricular ejection Fraction (LVEF) < or = 30%
- •Left atrial appendage is obliterated or surgically ligated
- •Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
- •Active endocarditis or other infection producing bacteraemia
- •Subject has a known malignancy or other illness where life expectancy is less than 2 years
- •Impaired renal function with eGFR <30 ml/min/1.73 m2
- •Echocardiographic Exclusion Criteria:
- •Intracardiac thrombus - including LAA - visualized by echocardiographic imaging
- •Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm2)
- •Cardiac tumour
- •LAA anatomy cannot accommodate an Omega™ device (as per IFU)
- •Placement of the device would interfere with any intracardiac or intravascular structure.
结局指标
主要结局
LAA (Left Atrial Appendage) closure
时间窗: According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place after the procedure - depending on local treatment standards).
The LAA closure is defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm and assessed by Transthoracic or Transoesophageal Echo or cardiac computed tomography, with colour flow Doppler.
Device related complications
时间窗: According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place around after the procedure - depending on local treatment standards).
Serious adverse events (SAE)
次要结局
- Procedure-related complications(Up to 7 days post-procedure)
- Device-related complications(24 months)
- Major bleeding(24 months)
- Ischemic stroke(24 months)
- Systemic embolism(24 months)
- Pericardial effusion/tamponade(24 months)
- Systemic embolism(24 months)
- Procedure-related complications(Up to 7 days post-procedure)
- Device-related complications(24 months)
- Major bleeding(24 months)
- Ischemic stroke(24 months)
- Pericardial effusion/tamponade(24 months)
- Technical success at implant(According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place around after the procedure - depending on local treatment standards).)
- Procedural success(According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place around after the procedure - depending on local treatment standards).)