CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Radiofrequency time
研究概览
简要总结
Prospective randomized study involving patients with typical flutter (TF) undergoing cavo-tricuspid isthmus (CTI) radiofrequency ablation. The aim is to compare the results of 3 different new ablation strategies using Omnipolar technology to classic linear ablation.
The investigators´ aim is to compare the effectiveness, safety and procedure times of CTI ablation with 3 different strategies using the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter to optimize radiofrequency (RF) and fluoroscopy times with classical linear ablation.
The number of patients needed to prove the investigators´ hypothesis is of at least 50 per group (total of 200 prospective patients
详细描述
Background Ablation procedures for CTI-dependent TF have classically been guided by fluoroscopy and intracavitary electrograms from diagnostic catheters placed in the right atrium (RA), the coronary sinus (CS) and the CTI (ablation catheter). Over the last few years, the use of navigators has increased considerably not only for complex procedures, but also for simple procedures, with the aim of reducing and even completely eliminating irradiation to both the patient and the operator (1). The investigators´ group is looking to characterize the high voltage and the low velocity regions in the CTI to minimize the procedure times. This has been addressed in a recent observational study with very good results.
Rationale There is increasing evidence of the benefits using 3D-systems not only to diminish fluoroscopy, but also to guide ablation targeting high voltage areas in the CTI (2-5). It is well known also the existence of low speed areas in the CTI, facilitating the presence of reentrant circuits (6,7). Currently, the investigators´ center performs all CTI ablation procedures using a 3D-navigator system, mostly with zero or minimal fluoroscopy. The investigators´ group has carried out a preliminary study with 13 patients to assess the effectiveness of CTI ablation with the use of the Ensite X navigator in magnetic mode with Omnipolar technology and HDGrid catheter. In this observational study the investigators were able to characterize the high voltage and the low velocity regions in the CTI to minimize the RF lesions and procedure times. Acute bidirectional block was achieved in 100% of patients with an average fluoroscopy time of 1 ± 2 min (77% patients with zero fluoroscopy) and an average RF time of 5,7 ± 3,2 min (38% below 3 min). This results were significantly lower than results obtained with classical linear ablation: median fluoroscopy time 19.3 min, IQR 12.9 to 36.4 min, median fluoroscopy dose 3520.7 cGycm(2), IQR 1700.0 to 6709.0 cGycm(2).
From the investigators´ point of view this observational study, together with previous evidence justify a randomized study in order to confirm our hypothesis:
Hypothesis Omnipolar technology is able to guide the ablation procedure minimizing both the RF time and the fluoroscopy time (compared to linear ablation) by targeting only the critical regions on the CTI. Therefore Omnipolar technology will diminish RF time and fluoroscopy time/exposition compared to classical CTI ablation, and by means of this the investigators expect an inferior complications rate. Importantly acute success rate and 6 months follow-up recurrences rate will remain similar.
OBJECTIVES
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
- Single (Participant)
盲法说明
Patient won´t know what strategy has been followed to achieve CTI block
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
- •Patients submitted to CTI ablation for TF
- •Age above 18 years
排除标准
- •Life expectancy of <1 year
结局指标
主要结局
Radiofrequency time
时间窗: 24 hours
Amount of Radiofrequency needed to achieve complete CTI block (acute success)
Fluoroscopy time
时间窗: 24 hours
Amount of Fluroscopy time needed to achieve complete CTI block (acute success)
Acute efficay
时间窗: 24 hours
Percentage of acute succeess (complete block of the CTI)
Radiation dose
时间窗: 24 hours
Amount of Radiation dose needed to achieve complete CTI block (acute success)
Zero Fluoroscopy
时间窗: 24 hours
Percentage of patients performed without the use of fluoroscopy
Complications
时间窗: 2 months
Percentage of procedural complications
次要结局
- Flutter recurrences(6 months)
研究者
Ermengol Vallès
Doctor
Parc de Salut Mar
