Segmental Substrate Isolation for the Treatment of Ventricular Tachycardia in Patients With Structural Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants achieving substrate Isolation with ablation of exit sites
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with structural heart disease undergoing VT ablation
排除标准
- •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
结局指标
主要结局
Number of participants achieving substrate Isolation with ablation of exit sites
时间窗: 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
次要结局
- VT invasive map exit and vMap exit match(Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.)
- Channel exit and vMap match(Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.)
- Inducibility post initial ablation(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(1 year: This will be measured for each subject up to 1 year after the study procedure.)