Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Subjects With Longstanding Persistent Atrial Fibrillation Requiring Mitral Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 5
- 主要终点
- Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation.
研究概览
简要总结
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF.
详细描述
Introduction
Among the cardiac arrhythmias, Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population and represents an increasing problem worldwide. Management strategies for AF include combinations of various treatments, including surgery. Cox et al. developed the surgical Maze procedure to restore sinus conduction to the AV node and to restore effective, synchronized bi-atrial contraction. In an effort to address the observed challenges and make this treatment available to more subjects, modifications of the Maze pattern and new lesion patterns have being developed and tested. Devices using new technologies, like cryothermia, were developed in an effort to reduce the time required to make the lesion pattern.The Cardioblate® CryoFlex™ Surgical Ablation System has been successfully used for the surgical ablation of cardiac arrhythmias including atrial fibrillation. The system utilizes cryothermia to create the linear lesions of the surgical Maze-III procedure.
Purpose: To provide clinical evidence showing that the Cox Cryo Maze III procedure is effective and safe in subjects with longstanding persistent AF undergoing mitral valve repair or replacement.
Study objective: The study objectives were to characterize the safety and efficacy of the Medtronic Cardioblate CryoFlex Surgical Ablation System when used to treat subjects with longstanding persistent AF requiring concomitant mitral valve repair or replacement.
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
- •Patients must have a documented history of longstanding persistent AF as defined by the HRS/EHRA/ECAS Guidelines
- •Patients should have a concomitant indication (other than AF) for open-heart surgery for mitral valve repair or replacement (bioprosthesis)
- •Patients should be older than or equal to 18 years of age
排除标准
- •Atrioventricular reentrant tachycardia (AVRT)
- •NYHA Class = IV
- •Left ejection fraction of ≤ 30%
- •Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery
- •Previous atrial fibrillation ablation, AV-nodal ablation, or surgical Maze procedure
- •Contraindication for anticoagulation therapy
- •Left atrial diameter > 7.0 cm
- •Preoperative need for intra-aortic balloon pump or intravenous inotropes
- •Renal failure requiring dialysis or hepatic failure
- •Life expectancy of less than one year
- •Pregnancy or desire to be pregnant within 12 months of the study treatment
- •Current diagnosis of active systemic infection
- •Documented MI 6 weeks prior to study enrollment
研究组 & 干预措施
Cardioblate CryoFlex Surgical Ablation
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery. During surgery, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor future episodes of AF.
干预措施: Cardioblate CryoFlex Surgical Ablation (Device)
Cardioblate CryoFlex Surgical Ablation
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery. During surgery, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor future episodes of AF.
干预措施: Mitral Valve surgery (Procedure)
Cardioblate CryoFlex Surgical Ablation
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery. During surgery, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor future episodes of AF.
干预措施: Medtronic Reveal XT Insertable Cardiac Monitor (Device)
Cardioblate CryoFlex Surgical Ablation
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery. During surgery, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor future episodes of AF.
干预措施: MAZE III (Procedure)
结局指标
主要结局
Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation.
时间窗: 12 months
The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden \< 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period.
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last
时间窗: 30 days
The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention
次要结局
- Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure(6 and 12 months)
- Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs(6 Months)
- AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months(3, 6 and 12 Months)
- Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last(12 months)