Pulmonary Vein Isolation Guided by Ablation Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to evaluate which ablation strategy increase the rate of WACA PV isolation, validated by mean of LASSO catheter, after first encirclement, from 70% to 80%.
研究概览
简要总结
This is a prospective, multi-center, research study designed to evaluate the acute achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool SmartTouch SF (STSF) catheter using the Ablation Index Module.
详细描述
This is a prospective, multi-center, research study designed to evaluate the acute achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool SmartTouch SF (STSF) catheter using the Ablation Index Module.
Subjects with paroxysmal and persistent atrial fibrillation (AF) will undergo catheter ablation using commercially approved devices (mapping system and catheters).
Patients will be followed up for 12 months to measure the recurrence of AF. This study is expected to start in September 2017 and to continue for approximately 26 months. It is anticipated that this study will require approximately 12 months for subject enrollment. Patients will be followed up for at least 12 months. Data analysis is expected to require approximately 2 months. At least 320 consecutive patients will be enrolled in the study centers. Patients will be divided in 4 groups and enrollment will stop when at least 80 patients will be enrolled in each group. The investigators evaluate two ablation catheters (ST and STSF) and two different ablation index settings (380 posterior - 500 anterior and 330 posterior - 450 anterior). Given that the rate of PV isolation with a standard wide antral circumferential ablation technique (WACA) is about 70%, the investigators want to test if one of two catheters or one of ablation index settings can increase the PV isolation rate of at least 10% (from 70% to 80%, 95% CI 75-85%).
Primary endpoint The primary objective of this study is to evaluate which ablation strategy increase the rate of WACA PV isolation, validated by mean of LASSO catheter, after first encirclement, from 70% to 80%.
Secondary endpoints Incidence of early PV reconnection 30 minutes after acute PV isolation. Difference in procedural and fluoroscopy time between the two groups. Incidence of AF recurrence during the blanking period (3-months after ablation).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Subject is indicated for catheter ablation for paroxysmal AF;
- •Subject is > 18 years old;
- •Subject is < 80 years old ;
- •Subject is on adequate anticoagulation therapy
排除标准
- •Patients who had already undergo an AF ablation procedure;
- •Patients with left ventricular ejection fraction < 35%
- •Women of childbearing potential who are or might be pregnant
- •Hematological contraindications to ionizing radiation exposure
- •Presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment
结局指标
主要结局
The primary objective of this study is to evaluate which ablation strategy increase the rate of WACA PV isolation, validated by mean of LASSO catheter, after first encirclement, from 70% to 80%.
时间窗: From the end of the WACA PV isolation up to 5 min after
次要结局
- Incidence of early PV reconnection 30 minutes after acute PV isolation.(Up to 30 min after the effective pulmonary vein isolation)
- Difference in procedural and fluoroscopy time between the two groups(From the beginning of the index procedure to the end of index procedure)
- Incidence of treatment-emergent adverse events.(Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, from the index procedure to one-year follow-up)
- Incidence of AF recurrence during the blanking period(Up to 3 months after the ablation procedure)