跳至主要内容
临床试验/NCT02799693
NCT02799693已完成不适用

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

John Sapp1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
John Sapp
入组人数
4
试验地点
1
主要终点
Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patient refusal to participate

结局指标

主要结局

Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure

时间窗: 6 months

Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.

Freedom from hospitalization for recurrent VT during 6 months following ablation

时间窗: 6 months

Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation

次要结局

  • Appropriate ICD shock(6 months)
  • VT storm(6 months)
  • VT events(6 months)
  • Recurrent VT(6 months)
  • Acute procedural complications(24 hours)
  • Acute Procedural Success(6 hours)
  • Number of inducible VT morphologies(6 hours)
  • ICD therapy - shocks(6 months)
  • ICD therapy - ATP(6 months)
  • Total appropriate ICD shocks(6 months)
  • ICD Therapy(6 months)
  • Appropriate ATP(6 months)
  • VT Storm(6 months)
  • Antiarrhythmic Drug Therapy(6 months)

研究者

发起方
John Sapp
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

John Sapp

MD FRCPC FRHS

Nova Scotia Health Authority

研究点 (1)

Loading locations...

相似试验