A Single-arm, Open Label, Multi-Centre Feasibility Study of the Aegis Sierra Ligation System in Left Atrial Appendage Closure in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- Number of participants free from the safety composite of device or procedure-related Major Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation System in accessing and closing off the left atrial appendage (LAA) using a minimally invasive epicardial access approach.
A minimum of 30 participants will be included in this study, which is being performed at a maximum of 8 centers in Canada and the United States. (A maximum of 15 participants at 4 US centers will be enrolled)
Participants will be considered for this treatment if their doctor(s) have determined they have documented non-valvular atrial fibrillation and are at increased risk for developing a stroke.
详细描述
Study Purpose:
The objective of this early feasibility study is to assess the safety and function of the Aegis Sierra Ligation System (SLS) in ligating the left atrial appendage in patients with non-valvular atrial fibrillation and at risk for stroke. The results of this trial will be used to inform a larger pivotal trial that will allow for further health technology assessment and for Medical Device License applications.
General Design:
This is a prospective, single-arm, open-label, multi-center study. This study will screen patients with atrial fibrillation at risk for stroke. A minimum of 30 patients that meet all of the study's inclusion criteria, none of the exclusion criteria and consent to study participation will be enrolled. Patient accruement will take place at up to 8 North American centers (A maximum of 15 participants at 4 US centers will be enrolled).
Each subject will undergo the following study visits: Screening, LAA ligation Procedure (Day 0) and Post-procedure, Hospital Discharge, Day 7, Day 30, Day 90, Day 180 and Day 365.
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
- •Age >=18 years
- •Documented non-valvular atrial fibrillation
- •Current CHA2DS2-VASc score of ≥2
- •Have an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation (OAC) therapy
- •Willing and able to provide written informed consent
- •Willing and able to comply with study procedures and follow-up visits.
- •Able to take antiplatelet therapy post ligation procedure
排除标准
- •Cardiogenic shock or hemodynamic instability
- •Myocardial infarction in the past 3 months
- •Cerebral embolism, stroke, or TIA in past 3 months
- •Absence of a defined left atrial appendage on echocardiogram or CT scan
- •Previous cardiac surgery involving opening of the pericardium
- •History of pericarditis or pericardial tumor, a history of constrictive pericarditis or features which in the opinion of the investigator are suggestive of constrictive pericarditis
- •History of significant chest trauma of the anterior chest
- •Estimated life expectancy < 24 months
- •Chemotherapy in the past 12 months
- •Prior thoracic radiation therapy
- •Chronic liver disease (greater than Child-Pugh Class A), chronic renal disease/insufficiency/failure (creatinine >3.0 mg/dL and/or renal replacement therapy at the time of screening), or chronic end stage pulmonary disease (FEV1 less than 30% predicted).
- •Current use of long-term treatment with steroids. Does not include intermittent use of inhaled steroids for respiratory diseases.
- •Contraindication to transesophageal echocardiography (TEE).
- •Absolute contraindication to anticoagulation or antiplatelet therapy
- •Congenital Heart Disease or intracardiac/intrapulmonary shunts
- •Symptomatic or known significant carotid disease and/ or aortic arch atheroma
- •Known thrombus in the LAA/LA or thrombus visualized by TEE within 48 hours before procedure
- •Left ventricular ejection fraction (LVEF) below 30%
- •Pregnant, breastfeeding or planning pregnancy within next 12 months
- •Inappropriate appendage morphology (aberrant anatomy) as determined by imaging and assessed by Central Screening Committee
- •Current NYHA Class IV heart failure symptoms
- •Right ventricular dysfunction and /or pulmonary hypertension (>=50mmHG)
- •Moderate or greater valve disease (i.e., MVA <1.5cm2, AVA <1.5cm2), history of rheumatic mitral stenosis, or mechanical valve prosthesis.
- •Cardiac tumour
- •Known hypersensitivity to nickel
- •Patients in whom pericardial access will put the patient at risk (e.g. scoliosis, pectus excavatum, massive obesity with a BMI >40) as determined by clinical site Principal Investigator or Central Screening Committee.
- •Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study.
- •Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study.
- •Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator or Central Screening Committee (e.g., uncontrolled drug and/or alcohol addiction, extreme frailty).
研究组 & 干预措施
Aegis Sierra Ligation System
The Aegis Sierra Ligation System is a series of devices designed for epicardial ligation of the Left Atrial Appendage through a minimally invasive transcatheter approach.
干预措施: Aegis Sierra Ligation System (Device)
结局指标
主要结局
Number of participants free from the safety composite of device or procedure-related Major Adverse Events
时间窗: Day 30 from procedure
Major Adverse Events : (defined as) * All-cause death * Stroke * Systemic embolism * Major or life-threatening bleeding (VARC-II definition), * Injury to coronary arteries requiring intervention, * Myocardial infarction (VARC-II definition), * Unplanned operation or interventional procedure for device or procedure related complications (including drainage of pericardial effusion), * Complications related to epicardial access
次要结局
- Number of participants that experience stroke(Day 30, 6-months and 1-year from procedure)
- Number of participants that experience a trans-ischemic attack (TIA)(Day 30, 6-months and 1-year from procedure)
- Number of participants that experience worsening heart failure(Day 30, 6-months and 1-year from procedure)
- Number of participants that achieve a residual flow ≤ 5mm distal to the closure site as measured by transesophageal echo (TEE)(Day 30, 6-months and 1-year from procedure)
- Number of participants that experience a safety composite event(Day 30, 6-months and 1-year from procedure)
- Number of participants that experience a new occurrence of left atrial thrombus(Day 30, 6-months and 1-year from procedure)
- The reported average change in the rating of atrial fibrillation burden as measured the University of Toronto Atrial Fibrillation Severity Scale (AFSS v. Sept 25, 2014)(Change between baseline to 6-months and 1-year from procedure)
- Number of participants that experience all-cause death(Day 30, 6-months and 1-year from procedure)
- Number of participants that experience systemic embolism(Day 30, 6-months and 1-year from procedure)
- Number of participants that experience an access site wound infection requiring IV antibiotics(Day 30, 6-months and 1-year from procedure)
- Number of participants that achieve Procedural Success(Hospitalization period)
- The reported average change in B-type Natriuretic Peptide (BNP)(Change between baseline and 6-months from procedure)
- The reported average change in Health Related Quality of Life scoring as measured by the Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT v.1.0)(Change between baseline to Day 30, 6-months, and 1-year from procedure)
- The average change in patient reported pain as measured by the Numeric Rating Scale (NRS-11) pain scale.(Change from baseline to hospital discharge, Day 7, and Day 30 from procedure)
- Number of participants that experience severe pericarditis(Day 30, 6-months and 1-year from procedure)
- Number of participants that achieve Technical Success(Assessed at end of procedure)