NCT01680757撤回4 期
Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 23
- 主要终点
- Rate of complete exclusion
研究概览
简要总结
This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Aged ≥ 21 years
- •Diagnosed non-valvular atrial fibrillation
- •Current CHADS2 score > 2
- •Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following: history of bleeding or high risk of bleeding; labile INR level (While on anticoagulation therapy, participant had INR results "out of therapeutic range" > 40% of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy).
- •Life expectancy of at least 1 year
- •Willing and able to return and comply with scheduled follow up visits
- •Willing and able to provide written informed consent
排除标准
- •Prior 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 within last 3 months
- •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 within the last 30 days
- •Transient ischemic attack (TIA) within the last 30 days
- •Current diagnosis of active systemic infection
- •eGFR < 60 mL/min/1.73m2 within last 3 months
- •Current renal failure requiring dialysis
- •ALT or AST level > 3 times upper level of normal, indicating hepatic failure. (NOTE: normal range provided by local laboratory performing the measurement), based on most recent pre-procedure assessment (within 30 days of study treatment)
- •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
- •Thrombocytopenia (platelet count < 100 x 109/L) based on most recent pre-procedure assessment (within 30 days of study treatment)
- •Anemia with hemoglobin concentration of < 10 g/dL based on most recent pre-procedure assessment (within 30 days of study treatment)
- •Pregnancy or desire to get pregnant within next 12 months.
- •Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry
- •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
Rate of complete exclusion
时间窗: During 1 year follow-up.
To assess the rate of complete exclusion of the left atrial appendage (defined as \< 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE).
次要结局
未报告次要终点
研究者
研究点 (23)
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