Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 12
- 主要终点
- Early safety (composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days)
研究概览
简要总结
Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very challenging in this population of complex and frail subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHMAN device proved promising safety and efficacy results in randomized comparisons with OAC (current standard of care), the aim of the current study is to assess the feasibility and the early safety of performing TAVI with the Lotus System and percutaneous LAA closure with the WATCHMAN device at the same session.
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
- 是
入选标准
- •TAVI candidates
- •Elderly patients with symptomatic, severe, calcific, native aortic valve stenosis, assessed by echocardiography AVA up to 1.0 cm2 or AVAi up to 0.6 cm2m2 and mean pressure gradient 40 mmHg or jet velocity 4 ms
- •Inoperable or at increased surgical risk (according to multidisciplinary heart team decision)
- •Non-valvular AF (paroxysmal, persistent or permanent)
- •CHA2DS2-VASc ≥ score
- •HAS-BLED score ≥ 2
- •Written informed consent
- •Aortic annulus size ≥ 20 mm and ≤ 27 mm
- •Adequate LAA ostium diameter (17 31mm)
排除标准
- •Previous TAVI
- •Previous LAA closure (surgical or percutaneous)
- •Previous RF ablation of AF
- •Need for long-term OAC (history of pulmonary embolism, mechanical heart valve)
- •Contraindication to aspirin
- •Relevant CAD requiring revascularization
- •Infective endocarditis
- •LV ejection fraction < 20 percent
- •Cardiogenic shock or hemodynamic instability
- •Symptomatic carotid disease
- •Life expectancy < 1 year
- •Severe renal failure (dialysis or serum creatinine level > 3.0 mg/dl or 265 μmol/L)
- •CVE within the past 3 months
- •Acute complications occurring during TAVI procedure
- •Congenital unicuspid aortic valve
- •Femoral artery lumen diameter <6.0 mm or <6.5 mm (for the 23-mm valve or the 25-mm and 27-mm valves, respectively)
- •Documented LAA and/or LV thrombi
- •Severe MR
- •Atrial septal defect
结局指标
主要结局
Early safety (composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days)
时间窗: 30 Days
Early safety - composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days. Composite defined as all cause-mortality, all stroke (disabling and non-disabling), life threatening bleeding, acute kidney injury (stage 2 or 3, including renal replacement therapy), coronary artery obstruction requiring intervention, major vascular complications, valve-related dysfunction requiring repeat procedure, pericardial effusion requiring pericardial drainage, and LAA device embolization requiring surgical intervention
次要结局
未报告次要终点