Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Time needed to block cavo-tricuspidal isthmus
研究概览
简要总结
Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.
详细描述
New porous tip catheters appear more effective in atrial fibrillation ablation than conventional irrigated catheter, with the same safety. We could hypothesize porous tip irrigated catheters are more effective than conventional irrigated catheter, reducing procedure time and RF ablation time.We realize a randomized comparison study.
For that, 70 patients with an indication for isthmus-dependent atrial flutter ablation will be randomized to conventional irrigated catheter ablation or porous tip irrigated catheter ablation. A ECG-Holter examination will be done at 1 month follow up after catheter ablation, 6 and 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All patients undergone to cti-dependent atrial flutter ablation.
排除标准
- •Left atrial flutter or atrial fibrillation
- •Femoral venous access not available.
- •Anticoagulation not therapeutic in patients at high thrombo-embolic risk
- •Other contraindications to radiofrequency ablations: pregnancy, malignancy
研究组 & 干预措施
Atrial flutter, irrigated catheter
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter
干预措施: Atrial flutter irrigated catheter (Device)
Atrial flutter, porous tip catheter
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter
干预措施: Atrial flutter porous tip catheter (Device)
结局指标
主要结局
Time needed to block cavo-tricuspidal isthmus
时间窗: During ablation procedure
次要结局
- Radiofrequency time.(During ablation procedure)
- Fluoroscopy time.(During ablation procedure.)
- Survival free from flutter(Up to 12 months after procedure.)
- Complications during the procedure.(During ablation procedure.)
研究者
Josep Lluis Mont Girbau
Head of the Arrhythmia Unit
Hospital Clinic of Barcelona