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临床试验/NCT07630480
NCT07630480已完成不适用

Three-Dimensional Electroanatomical Mapping Versus Conventional Fluoroscopy-Guided Slow Pathway Ablation for Typical Atrioventricular Nodal Re-Entrant Tachycardia: A Prospective Randomized Study

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年12月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Total Fluoroscopy Radiation Dose During Catheter Ablation

研究概览

简要总结

This prospective randomized interventional study compared conventional fluoroscopy-guided slow pathway ablation versus three-dimensional electroanatomical mapping-guided ablation in patients with electrophysiologically confirmed typical atrioventricular nodal re-entrant tachycardia (AVNRT). A total of 108 patients were screened for eligibility, of whom 80 eligible patients were randomized in a 1:1 ratio to either conventional fluoroscopic ablation or 3D mapping-guided ablation. Following post-randomization dropouts, the final analysis included 38 patients in the conventional group and 36 patients in the 3D mapping group. The study evaluated fluoroscopy exposure, procedural efficacy, complete slow pathway elimination, procedural success, complications, and arrhythmia recurrence during follow-up.

详细描述

Atrioventricular nodal re-entrant tachycardia (AVNRT) is one of the most common forms of paroxysmal supraventricular tachycardia. Catheter ablation targeting the slow AV nodal pathway is considered definitive therapy with high procedural success rates.

Conventional fluoroscopy-guided ablation mainly relies on anatomical landmarks and intracardiac electrogram interpretation. However, fluoroscopy exposure remains an important concern for both patients and operators. Three-dimensional electroanatomical mapping systems allow detailed reconstruction of the triangle of Koch and facilitate substrate-guided ablation using voltage, activation, and fractionated electrogram mapping techniques. These systems may reduce fluoroscopy exposure and improve procedural precision and efficacy.

This prospective randomized two-arm interventional study was conducted at the Cardiology Department, Kafr El-Sheikh University Hospital, between December 2023 and November 2025. A total of 108 consecutive patients with symptomatic supraventricular tachycardia suggestive of AVNRT were screened for eligibility. Following assessment according to predefined inclusion and exclusion criteria, 80 eligible patients with electrophysiologically confirmed typical AVNRT were enrolled and randomized in a 1:1 ratio to either conventional fluoroscopy-guided slow pathway ablation (Conventional group, n = 40) or three-dimensional electroanatomical mapping-guided slow pathway ablation (3D group, n = 40).

During the study period, post-randomization dropouts and exclusions occurred in both groups. Consequently, the final analysis included 38 patients in the conventional ablation group and 36 patients in the 3D mapping-guided ablation group.

In the conventional arm, ablation was performed using standard fluoroscopic anatomical landmarks and intracardiac electrogram criteria within the triangle of Koch. In the 3D mapping arm, high-density electroanatomical mapping using CARTO or EnSite X systems was performed with integrated voltage, activation, and fractionated electrogram mapping to identify optimal ablation targets.

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 (Outcomes Assessor)

盲法说明

Outcome assessment and follow-up evaluation were performed by investigators blinded to treatment allocation.

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

  • •Sustained symptomatic supraventricular tachycardia with surface ECG features highly suggestive of atrioventricular nodal re-entrant tachycardia (AVNRT).
  • •Electrophysiologically confirmed typical (slow-fast) AVNRT during the index electrophysiology study.
  • •Ability to provide written informed consent.

排除标准

  • •Coexisting arrhythmia requiring concurrent catheter ablation during the same procedure.
  • •Non-inducible AVNRT at the time of electrophysiological study.
  • •Antiarrhythmic drug use within 48 hours before the procedure or ongoing amiodarone therapy.
  • •Hemodynamic instability precluding safe catheter manipulation.
  • •Pregnancy.

研究组 & 干预措施

Conventional Fluoroscopy-Guided Ablation

Active Comparator

Patients underwent conventional fluoroscopy-guided slow pathway ablation using standard anatomical landmarks and intracardiac electrogram criteria within the triangle of Koch.

干预措施: Conventional Slow Pathway Ablation (Procedure)

3D Electroanatomical Mapping-Guided Ablation

Experimental

Patients underwent three-dimensional electroanatomical mapping-guided slow pathway ablation using CARTO or EnSite X systems with integrated voltage, activation, and fractionated electrogram mapping.

干预措施: 3D Electroanatomical Mapping-Guided Ablation (Procedure)

结局指标

主要结局

Total Fluoroscopy Radiation Dose During Catheter Ablation

时间窗: At completion of the index ablation procedure

Total fluoroscopy radiation dose measured during the catheter ablation procedure, reported in mGy.

Total Fluoroscopy Exposure Time During Catheter Ablation

时间窗: At completion of the index ablation procedure

Total duration of fluoroscopy exposure during the catheter ablation procedure, reported in minutes.

次要结局

  • Number of Participants With Complete Slow Pathway Elimination(At completion of the index ablation procedure)
  • Number of Participants with Acute Procedural Success(At completion of the index ablation procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Soha Mahmoud Ali Elshibly

Assistant lecturer at cardiology department, Kafr Elsheikh University

Kafrelsheikh University

研究点 (1)

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