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临床试验/NCT06669299
NCT06669299尚未招募不适用

The Value of Late Non-Invasive Programmed Stimulation (NIPS) in the Setting of Ventricular Tachycardia (VT) Ablation to Guide the Subsequent VT Therapeutic Strategies: a Prospective Randomized Multicenter Study

IRCCS Ospedale San Raffaele1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年12月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
51
试验地点
1
主要终点
VT recurrence free survival rate

研究概览

简要总结

The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. The primary objective is to establish whether a new VT ablation based on NIPS inducibility will reduce the risk of VT recurrence compared to antiarrhythmic drug therapy.

详细描述

The value of non-invasive programmed ventricular stimulation (NIPS) in the setting of ablation of ventricular tachycardia (VT) in patients with structural heart disease has been the object of studies in the last decade.

The technique is based on the feature, uniformly available in the Implantable Cardioverter-Defibrillator (ICD), to perform a complete programmed stimulation study from the apex of the right ventricle to assess the inducibility of ventricular tachycardia, similar to what is routinely performed during an invasive electrophysiology procedure. Data from our group indicate that 26% of patients who were non-inducible (apparent success) at the end of the ablation session become re-inducible to ventricular tachycardia at "late" NIPS (day 6). This finding, possibly related to partial recovery of conduction within the treated area, had prognostic significance, as it was associated with a 6-fold increased risk of VT recurrence at follow-up.

Recently Muser et al. reported similar findings (45/216 -21% of patients had clinical VT induced) with "late" NIPS performed on day 3. However, within this group of patients, the VT recurrence rate was significantly lower in those who had undergone, based on this finding, a re-do VT ablation as compared to those treated conservatively (rec in 1/11 of the Re-do ablation group, 9% vs. 24/34 in the conservative treatment group, 71%, p<0.01).

These data, however, originated from a retrospective observational analysis, where the indication of ablation was based on empirical physician preference.

No prospective randomized data compare the conservative attitude versus performing a new ablation in subjects who did not obtain a stable result after the first one. Therefore, this randomized multicenter clinical study aims to evaluate whether the repetition (Re-Do) of VT ablation process is superior to conservative medical therapy for reducing VT recurrences on post-procedural NIPS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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 with an implanted ICD (all brands)
  • Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the "index procedure", supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies: previous MI, myocarditis, ARVD, IDCM.
  • Induction of monomorphic VT at NIPS 3-7days after a successful index procedure
  • Age 18 years or more
  • Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol.

排除标准

  • Inducible VT after index procedure
  • Contraindication to anticoagulants
  • Presence of thrombi
  • Presence of Mitral and Aortic prosthetic valve
  • Recent (<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass
  • Pregnant or nursing
  • Ventricular Tachycardia caused by reversible pathology
  • < 1 Year life expectancy according to the investigator

研究组 & 干预措施

Group 1

Experimental

AAD therapy

干预措施: Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine) (Drug)

Group 2

Experimental

Re-Do ablation procedure

干预措施: Re-Do ventricular tachycardia ablation (Procedure)

结局指标

主要结局

VT recurrence free survival rate

时间窗: 12 months after the procedure

Compare the efficacy on the reduction of VT recurrence of a NIPS-based Re-Do VT ablation versus antiarrhythmic drug therapy

次要结局

  • Number of ICD shocks(Procedural, periprocedural, 6 and 12 months after procedure)
  • Proportion of patients with VT storm(Procedural, periprocedural, 6 and 12 months after procedure)
  • Rate of subsequent hospitalization for VT recurrence/HF.(Procedural, periprocedural, 6 and 12 months after procedure)
  • Cardiac mortality(Procedural, periprocedural, 6 and 12 months after procedure)

研究者

发起方
IRCCS Ospedale San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Paolo Della Bella

MD

IRCCS Ospedale San Raffaele

研究点 (1)

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