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Impact of Intraventricular Electrical Activation in Resynchronization Therapy (CARTO-CRT)

2015年3月5日 更新者:University Hospital, Bordeaux

Study of the Role of Intraventricular Electrical Activation in the Treatment of Congestive Heart Failure by Cardiac Resynchronization Therapy: Invasive Evaluation and Validation of Non-Invasive Strategy Using CardioInsight ®

Impact of intraventricular electrical activation in resynchronization therapy. We seek to evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to decrease the heterogeneity of LV activation in heart failure patients. A second goal is to evaluate the electrical determinant of clinical response to CRT using invasive and non-invasive mapping technology.

研究概览

详细说明

Comprehensive study, prospective, monocentric and cohort study.

Biventricular pacing is an effective therapy to improve end stage heart failure patients, however up to 30% of patients are unresponsive to this therapy. Among others, optimization of Left Ventricle (LV) pacing site location is critical to optimize response to Cardiac Resynchronization Therapy (CRT). Whether a better comprehension of baseline LV electrical activation can help to determine optimal LV lead location remains to be investigated.

After informed consent patients are included in the sudy. Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the LV cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Quantitative parameters: Global LV activation time (LVATG) (primary outcome); septal activation time (LVTAS); Global intra-LV dispersion time and Qualitative parameters: presence of intraLV line of block, area of late activation. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. A 3 and 6 months follow-up visit including clinical, biological evaluation (NYHA status, 6-min walking test, BNP) of the patients will be performed with an additional transthoracic echocardiography at 6 months.

研究类型

介入性

注册 (实际的)

18

阶段

  • 阶段2

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

      • Pessac、法国、33604
        • Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult (aged 18 or above)
  • Sinus rhythm
  • Patient must have signed informed consent
  • Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
  • Patient eligible for implantation of a ventricular resynchronization device or patient with a ventricular resynchronization device having a procedure of ventricular tachycardia ablation
  • Left ventricular ejection fraction <35%
  • NYHA Class II to IV with optimal medical treatment
  • Patient covered by national healthcare insurance

Exclusion Criteria:

  • Pregnant woman
  • Sequel of transmural myocardial infarction

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

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intraventricular Electrical Activation

Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the Left Ventricle (LV) cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT.

Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Evolution of the Global Left Ventricle activation time (LVATG) with and without Cardiac Resynchronization Therapy (CRT).
大体时间:Day 1 : End of CRT device implantation
Day 1 : End of CRT device implantation

次要结果测量

结果测量
大体时间
Number, area and location of line of conduction block in the Left Ventricle
大体时间:Day 1 : End of CRT device implantation
Day 1 : End of CRT device implantation
Area of the latest activated region of the Left Ventricle
大体时间:Day 1 : End of CRT device implantation
Day 1 : End of CRT device implantation
Number, area and location of LV region activated after the end of surface QRS
大体时间:Day 1 : End of CRT device implantation
Day 1 : End of CRT device implantation
Septal activation time (LVTAS)
大体时间:Day 1 : End of CRT device implantation
Day 1 : End of CRT device implantation
Global intra-Left Ventricular dispersion time
大体时间:Day 1 : End of CRT device implantation
Day 1 : End of CRT device implantation
Determination of the electrical parameters associated with good clinical response to CRT at 6 months.
大体时间:6 months after CRT device implantation
6 months after CRT device implantation
Non-invasive mapping: Same criteria evaluated non-invasively using CardioInsight ® with and without Cardiac Resynchronization Therapy activated.
大体时间:Between 3 to 7 days after CRT device implantation
Between 3 to 7 days after CRT device implantation

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2011年1月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2011年1月4日

首先提交符合 QC 标准的

2011年1月4日

首次发布 (估计)

2011年1月5日

研究记录更新

最后更新发布 (估计)

2015年3月6日

上次提交的符合 QC 标准的更新

2015年3月5日

最后验证

2015年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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