Impact of Intraventricular Electrical Activation in Resynchronization Therapy (CARTO-CRT)
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 ®
研究概览
地位
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
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Pessac、法国、33604
- Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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实验性的:Intraventricular Electrical Activation
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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 |
|---|---|
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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
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Day 1 : End of CRT device implantation
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number, area and location of line of conduction block in the Left Ventricle
大体时间:Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Area of the latest activated region of the Left Ventricle
大体时间:Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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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
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Day 1 : End of CRT device implantation
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Septal activation time (LVTAS)
大体时间:Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Global intra-Left Ventricular dispersion time
大体时间:Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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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
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6 months after CRT device implantation
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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
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Between 3 to 7 days after CRT device implantation
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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