EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 27
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type. Patients with POAF tend to have worse acute and long-term clinical outcomes. BoxX-NoAF is a randomized trial to evaluate if prophylactic ablation and exclusion of the Left Atrial Appendage at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
- •Age ≥ 65 years and CHA2DS2-VASc ≥ 3
排除标准
- •Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery
- •Prior procedure involving opening the pericardium or entering the pericardial space
- •Patients undergoing off-pump surgery
- •Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
- •Presence of a permanent pacemaker
- •Infiltrative cardiomyopathies (i.e. amyloidosis)
- •Planned cardiac surgical procedure using non-sternotomy approaches
- •Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices
- •Presence of ventricular arrhythmia
- •Active endocarditis
- •NYHA Class IV heart failure symptoms
- •Preoperative need for an intra-aortic ballon pump or intravenous inotropes
- •Active systemic infection at the time of cardiac surgery requiring antibiotics
- •Known allergy to Nitinol or nickel sensitivity
- •Known medical condition with expected survival of less than 1 year
- •Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits
- •Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial
- •Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
- •Pregnancy
- •Known severe symptomatic carotid disease
研究组 & 干预措施
Control
Index cardiac surgery only
Treatment
Index cardiac surgery + Ablation + Left Atrial Appendage Exclusion with AtriClip
干预措施: Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 30 days post index cardiac surgical procedure
The occurrence of clinically relevant post operative AF (POAF)
Primary Safety Endpoint
时间窗: 30 days post index cardiac surgical procedure
The composite of the following events: * All cause Mortality * Reoperation * Deep sternal wound infection * Permanent stroke * Prolonged ventilation * Renal failure * 30-day readmission * Atypical left atrial flutter * Phrenic nerve palsy * Major Bleeding
次要结局
- Powered Secondary Effectiveness Endpoint(3 years post index cardiac surgical procedure)