Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ability of test system (MAX-SRS) to record AF
研究概览
简要总结
Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.
详细描述
This is an acute study to test the ability of a custom external device (MAX-SRS) to sense atrial rhythms, determine when AF is present and deliver spatial resynchronization therapy (SRT) to terminate AF.
Patients will have commercially available diagnostic electrophysiologic catheters placed in the coronary sinus and on the heart. The catheters will be connected to the MAX-SRS. If AF is not present, standard pacing measures will be used to induce AF. Once > 1 minute of AF is recorded, the MAX-SRS will be activated to sense the rhythm and deliver SRT pacing to terminate the AF. Up to five SRT deliveries using the same or different SRT algorithms will be attempted. After the first successful termination of AF or after five SRT attempts the study is complete for each patient. Diagnostic catheters will be removed after the conclusion of the SRT pacing study.
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
- •Have AF that persists (Persistent AF) for more than 7 days but less than 1 year; OR has required cardioversion for termination of AF in the past 6 months; AND is not due to a reversible cause.
- •Be scheduled to undergo open-heart surgery
- •Be able to adhere to follow-up requirements
排除标准
- •Have active pericarditis or any systemic infection
- •Have left atrial thrombus (including left atrial appendage)
- •Have had a previous attempt to ablate atrial fibrillation
- •Scheduled for left atrial exclusion or excision
- •Have had previous surgical intervention in the left atrium, including left atrial appendage implant or exclusion
- •Have NYHA Class IV heart failure
- •Have long-standing persistent or permanent AF
- •Long-standing persistent AF is defined as AF that persists for greater than 1 year
- •Permanent AF is defined as AF where termination (sinus rhythm) is no longer pursued
- •Have any condition that prevents placement of a catheter on the posterior wall of the left atrium
- •History of Left Atrium (LA) infarction
结局指标
主要结局
Ability of test system (MAX-SRS) to record AF
时间窗: 60 seconds
Record 1 run of AF = 60 seconds, categorical variable (Yes/No)
Mean SRT pacing duration per SRT pacing attempt
时间窗: min:sec/attempt
Record duration (min:sec) of each SRT pacing attempt
次要结局
- Mean SRT pacing duration to convert AF(Mean duration (min:sec) of SRT pacing to organize clinical rhythm or terminate AF during the intra-operative procedure.)