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
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- LAA closure
研究概览
简要总结
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber. Plugging this appendage with an implantable plug type device, which is placed via a catheter painlessly in the femoral vein, has been proven to be a reliable alternative to the standard anti-clotting medication in a number of recent international trials. The Omega device is a new design of such a plug, made from biocompatible and compressible nitinol and fabric.
Up to 195 patients will be enrolled in Europe, assuming that enrolment will stop once the Omega™ device has been successfully implanted in 150 evaluable patients.
The primary performance endpoint of the study is LAA closure (defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm) at 60 days (+/- 15 days) visit documented by transoesophageal echocardiogram (TEE/TOE) with colour flow Doppler.
详细描述
This is a single arm study to assess the safety and performance of the Omega™ Left Atrial Appendage (LAA) Occluder in patients with Non-valvular atrial fibrillation (NVAF) and high bleeding risk.
The study will be conducted in accordance with the ISO standard ISO 14155 (Clinical investigation of medical devices for human subjects - Good clinical practice) and other legal requirements as applicable.
The primary performance endpoint of the study is LAA closure (defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm) at 60 days (+/- 15 days) visit documented by transoesophageal echocardiogram (TEE/TOE) with colour flow Doppler.
The primary safety endpoint of the study is device-related complications (serious adverse events [SAEs]) through 60 days (+/- 15 days) post-procedural.
Following consent a number of assessments will be undertaken prior to the procedure to ensure the study eligibility criteria are met. These assessments include; medical history, physical exams, ECG, blood tests, transthoracic echocardiogram, transesophageal echocardiogram and cardiac CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 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 CHADS2 score > 2 or a CHA2DS2-VASc score > 3
- •Deemed, by investigator, to be unsuitable or contraindicated for long term oral anticoagulation therapy due to high bleeding risk
- •To have suitable anatomy for percutaneous LAA occlusion procedure with a single Omega™ device based on CT scan evaluation
- •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
- •Able to and willing to return for required follow-up visits and examinations.
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 undergone surgical atrial septal defect (ASD) repair or has an ASD closure device implanted
- •Has undergone surgical patent foramen ovale (PFO) repair or has a PFO closure device implanted
- •Implanted with a mechanical heart valve prosthesis thus requiring long term oral anticoagulation
- •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)
- •Stroke or transient ischemic attack (TIA) within 90 days prior to implant procedure
- •Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to implant, or intervention or surgery is planned within 60 days after 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) <30%
- •Symptomatic carotid artery disease (defined as >50% reduced diameter with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is >50% reduced diameter
- •Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- •History of idiopathic or recurrent venous thromboembolism requiring long term oral anticoagulation
- •Left atrial appendage is obliterated or surgically ligated
- •Resting heart rate >110 bpm
- •Thrombocytopenia (defined as < 70,000 platelets/mm3) or anaemia with haemoglobin concentration of < 10 g/dl (i.e. anaemia as determined by the investigator which would require transfusion)
- •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 <40 ml/min/1.73 m2
- •More than mild hepatic failure, i.e. ALT, AST, or Alkalic Phosphatase >2× upper limit of normal
- •Echocardiographic Exclusion Criteria:
- •Intracardiac thrombus - including LAA - visualized by echocardiographic imaging
- •Existing circumferential pericardial effusion >2mm
- •Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm2)
- •High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (atrial septal excursion >15mm; excursion defined as maximal protrusion of the ASA beyond the plane of the atrial septum during cardiac cycle) or large shunt (substantial passage of bubbles, i.e. >25, within 3 cardiac cycles from appearing in the right atrium)
- •Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
- •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 closure
时间窗: at 60 days (+/- 15 days)
Complete seal or efficient seal with a peri-device leak ≤ 5 mm documented by transoesophageal echocardiogram (TEE/TOE) with colour flow Doppler.
Device-related complications
时间窗: through 60 days post-procedure
Serious adverse event criteria set out in the protocol and being assessed as related to the study device.
次要结局
- Major bleeding(From procedure to 12 months)
- Procedure-related complications(1 to 6 days post-procedure)
- Ischemic stroke(From procedure to 12 months)
- Systemic embolism(From procedure to 12 months)
- Pericardial effusion/tamponade(From procedure to 12 months)
- Technical success(At implant)
- Procedural success(At procedure)