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临床试验/NCT06492499
NCT06492499已完成不适用

Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy Radiofrequency Catheter Ablation for Atrioventricular Nodal Reentrant Tachycardia

Ning Zhou1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Non-inducibility of Atrioventricular Nodal Reentrant Tachycardia (AVNRT)

研究概览

简要总结

This study aims to evaluate the viability and therapeutic efficacy of zero-fluoroscopy radiofrequency catheter ablation (RFCA) using the superior vena cava (SVC) approach in patients with atrioventricular nodal reentrant tachycardia (AVNRT). The study compares outcomes between the SVC approach and the conventional inferior vena cava (IVC) approach. Patients diagnosed with AVNRT who underwent RFCA between June 2022 and October 2022 were retrospectively analyzed. The primary outcome measure is the non-inducibility of AVNRT, while secondary outcomes include postoperative recovery time and complication rates. The study seeks to provide a safer and more efficient RFCA method, enhancing patient recovery by minimizing radiation exposure and optimizing catheter access routes.

详细描述

This retrospective study investigates the feasibility and therapeutic efficacy of zero-fluoroscopy radiofrequency catheter ablation (RFCA) using the superior vena cava (SVC) approach in patients diagnosed with atrioventricular nodal reentrant tachycardia (AVNRT). The study was conducted at our institution between June 2022 and October 2022, including adult patients (age >18 years) who underwent RFCA during this period. Patients were divided into two groups based on the catheter access site: the SVC approach group and the inferior vena cava (IVC) approach group.

The primary objective of the study is to assess the success rate of AVNRT ablation using the SVC approach compared to the conventional IVC approach, under zero-fluoroscopy conditions. Secondary objectives include evaluating the postoperative recovery time, incidence of complications, and overall patient outcomes.

Inclusion criteria required that patients experienced at least one episode of AVNRT during transesophageal atrial pacing (TEAP) and programmed stimulation. Exclusion criteria included cases where AVNRT was attributed to reversible causes such as acute myocarditis, cardiac surgery, or other types of tachycardias (e.g., atrial tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia).

The electrophysiologic study involved TEAP and programmed stimulation to screen for AVNRT and exclude other arrhythmias. The catheterization procedure was performed under conscious sedation and local infiltration anesthesia, with continuous monitoring of vital signs. Catheter access sites for the SVC group included the median cubital vein and the basilic vein, while the femoral vein was used for the IVC group. The ablation procedure utilized a large-tip electrode catheter for mapping and ablation, guided by the EnSite NavX system.

Ablation endpoints were determined by the non-inducibility of AVNRT after programmed stimulation. Follow-up evaluations included monitoring for recurrence of atrial arrhythmias or the occurrence of iatrogenic atrioventricular block (AVB). Statistical analysis was performed using R 4.4.0 software, with continuous variables expressed as mean ± SD or median (interquartile range) and categorical variables as counts or percentages. An unpaired t-test or nonparametric test was used to compare the SVC and IVC approach groups, with a p-value of <0.05 considered statistically significant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Adults aged >18 years.
  • Diagnosed with atrioventricular nodal reentrant tachycardia (AVNRT).
  • Underwent radiofrequency catheter ablation (RFCA) at our institution between June 2022 and October
  • Experienced at least one episode of AVNRT during transesophageal atrial pacing (TEAP) and programmed stimulation.
  • Provided informed consent for the procedure and data collection.

排除标准

  • AVNRT attributed to reversible causes, such as acute myocarditis or recent cardiac surgery.
  • Presence of other types of tachycardias (e.g., atrial tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia).
  • Inability to abstain from pharmacological interventions for at least five half-lives of the medication prior to TEAP.
  • Contraindications for the use of conscious sedation or local anesthesia.
  • Severe comorbidities that would interfere with study participation or follow-up.
  • Patients who are pregnant or lactating.
  • Previous RFCA procedures for AVNRT within the past six months.

结局指标

主要结局

Non-inducibility of Atrioventricular Nodal Reentrant Tachycardia (AVNRT)

时间窗: During the procedure

This is determined during the procedure by performing programmed stimulation to test for the presence of AVNRT. Non-inducibility is confirmed if AVNRT cannot be induced following the ablation, indicating a successful therapeutic intervention.

Recurrence of supraventricular tachycardia

时间窗: Within 1 year post-procedure

It is defined as any documented episode of supraventricular tachycardia, such as AVNRT, atrial fibrillation, or atrial flutter, confirmed by electrocardiographic evidence.

次要结局

  • Postoperative Recovery Time(Within 24 hours post-procedure)
  • Complication Rate(Within 1 year post-procedure)

研究者

发起方
Ning Zhou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ning Zhou

Professor

Tongji Hospital

研究点 (1)

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