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临床试验/NCT05709795
NCT05709795Unknown不适用

CTI Ablation Guided by Omnipolar Wave Speed and Voltage Maps to Diminish RF and Fluoroscopy Times

Parc de Salut Mar4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年3月1日最近更新:
适应症

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

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

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ermengol Vallès

Doctor

Parc de Salut Mar

研究点 (4)

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