NCT02059707已完成不适用
LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS Suture Delivery Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Percent of subjects with complete exclusion
研究概览
简要总结
The objective is to assess the effectiveness of permanent exclusion of the LAA with the LARIAT RS Suture Delivery Device and accessories in AF patients.
详细描述
Prospective, observational, single-center, non-randomized study of a stand-alone procedure for the exclusion of the LAA with the LARIAT RS in patients with atrial fibrillation. Completed LAA exclusion will be assessed by TEE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •Diagnosed non-valvular atrial fibrillation
- •Current CHADS2 score ≥ 2
- •Poor candidate (e.g., contraindicated, labile INR, non-compliant, etc.) for anticoagulation (e.g., warfarin, dabigatran, apixaban, and rivaroxaban)
- •Life expectancy of ≥ 1 year
- •Willing and able to provide written informed consent
- •Willing and able to come to and comply with scheduled follow-up visits
排除标准
- •Previous cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
- •Prosthetic heart valve or ring in any position
- •Current NYHA Class IV heart failure symptoms
- •Current right heart failure
- •Myocardial infarction or unstable angina within last 3 months
- •Current cardiogenic shock or hemodynamic instability
- •Current symptomatic carotid disease
- •Need for an intra-aortic balloon pump or intravenous inotropes
- •Embolic stroke or transient ischemic attack (TIA) within the last 30 days.
- •Current diagnosis of active systemic infection
- •Need for emergent cardiac surgery (e.g., cardiogenic shock)
- •Current renal failure requiring dialysis
- •Current clinical evidence of cirrhosis
- •Any history of thoracic radiation
- •Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
- •Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
- •Any history of pericarditis
- •Pectus excavatum (clinically defined by treating physician)
- •Severe scoliosis
- •Pregnancy or desire to get pregnant within the next 12 months.
- •LVEF < 30%
- •Current participation in a clinical investigation that involves an active treatment arm.
- •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 (e.g., an uncontrolled drug and/or alcohol addiction)
结局指标
主要结局
Percent of subjects with complete exclusion
时间窗: 90 days
To assess the rate of complete exclusion of the LAA measured by color duplex TEE at 4 time points: Acute (i.e., immediately after LAA exclusion procedure), 1 day, 1 month, and 3 month.
次要结局
- Secondary Exploratory objectives of procedural success and device-related complication rates(3 month)
研究者
研究点 (1)
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