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Targeted Ablation to Isolate Scar Channels Causing Ventricular Tachycardia

2026年9月8日更新者：New York Medical College

Segmental Substrate Isolation for the Treatment of Ventricular Tachycardia in Patients With Structural Heart Disease

The goal of this study is to map conducting channels within scar that cause ventricular tachycardia (VT) in patients with scar in their hearts in order to block these channels from causing VT with targeted radiofrequency ablation (cautery).

Participants undergoing VT ablation mapping of these channels by pacing many sites within the scar area and determining where these channels exit the scar into normal tissue. These exits will be ablated. Immediate success and success at 1 year will be evaluated.

研究概览

地位

招聘中

条件

干预/治疗

程序：Selective Substrate Isolation

详细说明

After standard VT induction and mapping procedures (noninvasive identification of induced VT exit sites with Vektor vMap; substrate mapping; initial pacemapping), the study will consist of pacing within the substrate and mapping all channel exits both noninvasively with vMap as well as invasively with high density mapping catheters within the heart by escape mapping (all paced sites creating a consistent paced morphology, up to the shortest stimulus-to-QRS interval achieved) as well as focal activation mapping of this channel exit while pacing within the channel. The noninvasive map will aid in focusing invasive mapping to a small area of the substrate. Once the exit sites are determined, ablation energy will be delivered based on the mapped exit sites in the substrate channel within 0.5cm of the exit with the goal of blocking each exit site mapped. After the ablation lesion set is delivered, repeat attempt to induce VT will be performed. If more VT is induced, additional ablation energy will be delivered guided by standard mapping techniques (substrate, slow conduction zones, pacemapping).

研究类型

观察性的

注册 (估计的)

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

美国
- New York
  - Valhalla、New York、美国、10595
    - 招聘中
    - Westchester Medical Center
    - 副研究员：
      
      Daniel Frenkel, MD
    - 接触：
      
      Jason T Jacobson, MD
      
      电话号码：9144935314
      
      邮箱：Jason.Jacobson@wmchealth.org
    - 接触：
      
      Sei Iwai, MD
      
      电话号码：9149096900
      
      邮箱：Sei.Iwai@wmchealth.org
    - 首席研究员：
      
      Jason Jacobson, MD
    - 副研究员：
      
      Sei Iwai, MD

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

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients presenting to Westchester medical Center for ablation of VT with structural heart disease

描述

Inclusion Criteria:

Patients with structural heart disease undergoing VT ablation

Exclusion Criteria:

Unable or unwilling to sign consent
Cardiogenic shock or NYHA Class IV heart failure and not a candidate for mechanical circulatory support for the procedure (percutaneous left ventricular assist device (LVAD), extracorporeal membrane oxygenation, or implanted LVAD)
Absence of substrate during initial voltage mapping

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

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
Number of participants achieving substrate Isolation with ablation of exit sites 大体时间：Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.	Inability to stimulate the ventricle (physiologic parameter) while pacing in the substrate area contained by the ablation lines through each pacemap exit, at sites that were able to stimulate the ventricle prior to ablation. This will be manifest by the absence of a QRS complex resultant from the pacing stimulus. This is a	Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.

次要结果测量

结果测量	措施说明	大体时间
VT invasive map exit and vMap exit match 大体时间：Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.	Percent matching of VT exits determined by activation/entrainment/pace mapping for matched ECG morphologies with vMap determined exits	Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
Channel exit and vMap match 大体时间：Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.	Percent matching of noninvasively mapped exit sites compared with invasively mapped channel exits	Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
Inducibility post initial ablation 大体时间：Perioperative/Periprocedural: This will be measured during the study ablation procedure, after the first set of radiofrequency lesions is placed based in initial mapping.	VT inducibility after first lesion sets determined by channel mapping	Perioperative/Periprocedural: This will be measured during the study ablation procedure, after the first set of radiofrequency lesions is placed based in initial mapping.
1 year outcome 大体时间：1 year: This will be measured for each subject up to 1 year after the study procedure.	VT recurrence at 1 year determined by therapies delivered by implantable cardioverted defibrillator and presentation with sustained VT below ICD detection.	1 year: This will be measured for each subject up to 1 year after the study procedure.

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

New York Medical College

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)

2025年3月27日

初级完成 (估计的)

2027年12月9日

研究完成 (估计的)

2028年12月9日

研究注册日期

首次提交

2025年6月17日

首先提交符合 QC 标准的

2026年9月8日

首次发布 (实际的)

2026年9月10日

研究记录更新

最后更新发布 (实际的)