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临床试验/NCT05777850
NCT05777850招募中不适用

High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter

Jose Luis Ibañez Criado2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
2
主要终点
Safety primary outcome: incidence of procedure-related complications.

研究概览

简要总结

The aim of cavotricuspid isthmus (CTI) dependent flutter ablation is the bidirectional conduction block of CTI. The probability of achieving a permanent bidirectional block at the CTI depends, mainly, on the ablation energy applied and the quality of the obtained lesion. Among the factors that determine the lesion's quality those which have the bigger impact are catheter stability, contact force, power and duration of energy application and the temperature reached at depth.This is a multicenter 1:1 randomized, blinded (open for the operator) study. Two CTI ablation strategies are compared: 1) conventional treatment branch which consists of individual 25-40 W applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers (Ablation Index >500 at the anterior half of the CTI and >400 at the posterior half with de CARTO 3 system; 2) experimental treatment branch consistent of CTI block using individual high power (90W) short duration (4 seconds) point-by-point applications. The main objective of this study is assessing the non-inferiority of the efficacy and safety of high-power short-duration ablation in patients undergoing typical atrial flutter ablation. Secondary objectives include the comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure and time to atrial flutter recurrence.

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
Double (Participant, Investigator)

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 with cavotricuspid isthmus dependent flutter referred to ablation
  • Patients clinically and hemodynamically stable.
  • Patients who give informed consent.

排除标准

  • Refusal to participate in the register or inability to understand the informed consent.
  • Age under
  • Patients who have already undergone previous flutter ablation procedures.

结局指标

主要结局

Safety primary outcome: incidence of procedure-related complications.

时间窗: One year

Number of procedure-related complications from the time of the ablation until the last follow-up visit.

Efficacy primary outcome: typical atrial flutter recurrence.

时间窗: One year

Incidence of typical atrial flutter recurrence during a one-year follow-up period. To be considered clinically relevant the recurrence must be documented by a full EKG made because of patients' symptoms or any typical atrial flutter detected by an EKG, 24h Holter-EKG or events-monitoring device that will be performed at least at a 6 months and 12 months follow-up visits.

次要结局

未报告次要终点

研究者

发起方
Jose Luis Ibañez Criado
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jose Luis Ibañez Criado

Medical Doctor

Hospital General Universitario de Alicante

研究点 (2)

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