"Bidirectional Conduction Block of Left Atrial Anterior Line in Patients With Left Atrial Ablation - Reduction of RF Applications Using the Thermocool SmartTouch Contact Force Sensing Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)
研究概览
简要总结
This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.
详细描述
Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial fibrillation (AF).
The three main techniques described for ablation of persistent AF include pulmonary vein (PV) isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.
The ideal endpoint of linear lesions should be complete electrical block; however, this is technically challenging, time consuming, and potentially hazardous. The ST catheter combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will allow physicians to more safely and effectively treat atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic atrial fibrillation and additional substrate modification or perimitral flutter
- •Patients with persistent atrial fibrillation
- •Patients with perimitral flutter
- •Patients with recurrence after a circumferential PV isolation procedure
- •Patients with paroxysmal atrial fibrillation and AF episodes lasting > 7 days
- •Patients (>18 und <80 Jahre)
排除标准
- •moderate to severe valvular heart disease,
- •congenital heart disease
- •reduced left ventricular function (ejection fraction <35%)
- •any reversible cause for atrial fibrillation (e.g. hyperthyroidism)
- •intracardiac thrombi documented by transesophageal echocardiography
- •myocardial infarction within 3 months, cardiac surgery in the previous three months
结局指标
主要结局
Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)
时间窗: 30 minutes
次要结局
- Achievement of primary endpoint (bidirectional conduction block at an anterior line)(6 months)
研究者
Heidi Estner
Director Interventional Electrophysiology
LMU Klinikum