Evaluation of the Safety and Performance of the Very High Power-Short Duration QDOT Strategy in Patients Referred for Atrial Fibrillation Ablation.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- isolation efficacy
研究概览
简要总结
The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).
详细描述
The very high power-short duration (vHPSD) catheter, is a novel CF catheter optimized for temperature-controlled ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring during ablation. The associated vHPSD algorithm modulates power to maintain target temperature during these vHPSD lesions (90 W, 4 s). In preclinical models, vHPSD ablation with this novel catheter has improved atrial linear lesion contiguity, transmurality, and durability and has substantially reduced radiofrequency ablation times, but with a safety profile similar to those of standard irrigated radiofrequency ablation catheters.
The QDOT -FAST study demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters.
The aim of the present study is to compare the safety and short-term performance between THERMOCOOL SMARTTOUCH SF-5D QDOT system used with fast ablation mode and the standard Thermocool Smartouch SF in treatment of patients with atrial fibrillation (AF).
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
- 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
- •Male and female >18 years old.
- •Subjects must provide written informed consent to participate in the study.
- •Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
排除标准
- •Pregnant women.
- •Patients with iodine contrast media allergy
- •Patients with renal failure (GFR <60ml/min)
结局指标
主要结局
isolation efficacy
时间窗: 1 day
The first time pulmonary vein isolation (percentages of success)
procedure time
时间窗: 1 day
The procedural and fluoroscopy time required for the procedure (in minutes).
Recurrence of AF
时间窗: 1 year
Recurrence of AF (will be assessed by Holter monitoring)
次要结局
未报告次要终点
研究者
michal roll
PI
Tel-Aviv Sourasky Medical Center