跳至主要内容
临床试验/NCT05888662
NCT05888662招募中不适用

Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients Withischemic Cardiomyopathy: a Randomized Controlled Study

Rennes University Hospital15 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年10月23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
150
试验地点
15
主要终点
Survival free from ventricular arrhythmia recurrence

研究概览

简要总结

Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV.

First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial.

For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences.

The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.

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
None

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 over 18 years of age
  • 1st radiofrequency ablation of VT complicating ischaemic heart disease
  • Patients with an ICD and remote monitoring
  • Having, for women of childbearing age, effective contraception until discharge from hospital
  • Have given their free and informed consent in writing
  • are affiliated to or have health insurance

排除标准

  • History of cardiac surgery compromising the epicardial approach (coronary artery bypass grafting, valve replacements, or other surgeries that may have caused pericardial adhesions)
  • Presence of a left intraventricular thrombus found during pre-procedure imaging
  • Anticoagulant therapy that cannot be temporarily discontinued
  • Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy
  • History of pericarditis
  • Previous thoracic radiotherapy
  • Contraindication to general anaesthesia
  • Pregnant or breastfeeding woman
  • History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure)
  • Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent

结局指标

主要结局

Survival free from ventricular arrhythmia recurrence

时间窗: up to 5 years

Survival free from ventricular arrhythmia recurrence, defined as the time interval between the date of ablation and the date of first ventricular arrhythmia recurrence. Recurrence of ventricular arrhythmia is defined as the occurrence of appropriate ICD therapy or the occurrence ventricular arrhythmia requiring hospitalisation. The occurrence of the event and the date of the event will be obtained from the ICD interrogation. Patients without recurrence will be censored at the date of last ICD interrogation

次要结局

  • Number of ventricular arrhythmias treated(up to 5 years)
  • Percentage of patients with recurrent ventricular arrhythmia(up to 5 years)
  • Percentage of patients with a electrical storm(up to 5 years)
  • Number of serious complications(up to 5 years)
  • Number of patients hospitalized for cardiovascular reasons(up to 2 years)
  • Number of patients requiring a redo ablation for ventricular arrhythmia(Up to 5 years)
  • mortality rate(Up to 2 years)
  • Number of patients in each group who are non-inducible at the end of the procedure(1 day)
  • Length of hospital stay (from surgery to return home)(Up to 2 years)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (15)

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