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Intramural Needle Ablation for Ventricular Tachycardia

2022年3月14日更新者：John Sapp

Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation

This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Following ablation, patients will be monitored for 6 months. The duration of the study is up to 4 years.

研究概览

地位

完全的

条件

复发性室性心动过速

详细说明

This is an observational prospective cohort study of patients undergoing needle catheter ablation. Patients with recurrent sustained or incessant ventricular tachycardia who have recurrent monomorphic ventricular tachycardia that has failed antiarrhythmic drug therapy and prior catheter ablation who are undergoing intramural needle ablation for VT will be offered participation. Data will be collected during the procedure and during follow-up. Patients will be monitored in hospital for complications and during 6 months follow-up.

Data Collection:

Baseline Data: Baseline demographic information and a narrative medical history will be collected on all patients, including documentation of prior cardiac history, and arrhythmia history, as well as prior medications and cardiac procedures.

Procedural data: Details of the procedure including both procedural methods and arrhythmias induced, ablation parameters, needle deployments, recordings and response to procedure.

Followup data: Adverse events will be collected for events which are documented during enrollment and follow-up. During follow-up, hospitalizations will be collected, need for further procedures, implantable defibrillator therapies and procedures will be collected, as well as follow-up echocardiography findings.

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- Nova Scotia
  - Halifax、Nova Scotia、加拿大、B3H 3A7
    - QEII Health Sciences Centre

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with recurrent ventricular tachycardia who have failed radiofrequency catheter ablation who are undergoing intramural needle catheter ablation procedures.

描述

Inclusion Criteria:

Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.

Exclusion Criteria:

Patient refusal to participate

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：队列
时间观点：预期

团体/队列数

队列和干预

团体/队列
Recurrent VT failing RF ablation Patients undergoing intramural needle catheter ablation of recurrent monomorphic ventricular tachycardia who have failed prior attempted radiofrequency catheter ablation.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Freedom from hospitalization for recurrent VT during 6 months following ablation 大体时间：6 months	Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation	6 months
Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure 大体时间：6 months	Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.	6 months

次要结果测量

结果测量	措施说明	大体时间
Acute Procedural Success 大体时间：6 hours	Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible	6 hours
Acute procedural complications 大体时间：24 hours	Any complications occurring within 24 hours post procedure described as probably or possibly related to the VT catheter ablation procedure	24 hours
Number of inducible VT morphologies 大体时间：6 hours	Number of VT morphologies induced during catheter ablation	6 hours
ICD therapy - shocks 大体时间：3 months	Number of VT events treated with appropriate ICD shocks at 3 months post procedure	3 months
ICD therapy - shocks 大体时间：6 months	Number of VT events treated with appropriate ICD shocks at 6 months post procedure	6 months
ICD therapy - ATP 大体时间：3 months	Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure	3 months
ICD therapy - ATP 大体时间：6 months	Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure	6 months
ICD Therapy 大体时间：3 months	Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure	3 months
ICD Therapy 大体时间：6 months	Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure	6 months
VT storm 大体时间：3 months	Number of VT storm events during 3 months follow-up	3 months
VT storm 大体时间：6 months	Number of VT storm events during 6 months follow-up	6 months
VT events 大体时间：3 months	Difference in number of VT events during 3 months prior to and following procedure	3 months
VT events 大体时间：6 months	Difference in number of VT events during 6 months prior to and following procedure	6 months
Recurrent VT 大体时间：6 months	Time to first recurrent VT	6 months
Appropriate ATP 大体时间：6 months	Time to first appropriate ATP	6 months
Appropriate ICD shock 大体时间：6 months	Time to first appropriate ICD shock	6 months
VT Storm 大体时间：6 months	Time to first VT storm	6 months
Antiarrhythmic Drug Therapy 大体时间：6 months	Changes in antiarrhythmic drug therapy post-procedure	6 months
Total appropriate ICD shocks 大体时间：3 months	Total number of appropriate ICD shocks during 3 months follow up	3 months
Total appropriate ICD shocks 大体时间：6 months	Total number of appropriate ICD shocks during 6 months follow up	6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

John Sapp

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年7月1日

初级完成 (实际的)

2018年4月5日

研究完成 (实际的)

2018年5月30日

研究注册日期

首次提交

2016年6月2日

首先提交符合 QC 标准的

2016年6月10日

首次发布 (估计)

2016年6月15日

研究记录更新

最后更新发布 (实际的)

2022年3月15日

上次提交的符合 QC 标准的更新

2022年3月14日

最后验证

2022年3月1日