Fibrillatory Factor in Ventricular Tachycardia
Using Fibrillatory Factor to Predict the Source of Ventricular Tachycardia in Man
This study involves recording electrical signals inside the heart during an ablation procedure. It is thought that by studying these electrical signals in detail the investigators may be able to better identify and treat patients at risk of Ventricular Tachycardia (VT).
VT is where the lower chambers (ventricles) of your heart beat fast and this condition can be life-threatening. An ablation procedure is performed in patients who have VT despite the best treatment available with tablets.
Cardiac ablation involves interrupting the abnormal electrical signals, which cause VT, by applying a type of electrical energy through a catheter. An important part of the ablation procedure is the identification of the exact part of the heart muscle responsible for causing the VT. This typically involves sampling the electrical signals in lots of different areas of the heart, which allows the construction of computer generated 3 dimensional pictures of the structure and the electrical circuits inside the ventricle. Recent research has identified a new method to interpret these electrical signals (called Fibrillatory Factor - FF), which may allow better identification of the area within the ventricle that should be ablated.
A standard VT ablation will often involve us controlling the heart-beat by pacing the heart through 1 of the investigators catheters within the heart. The electrical response to pacing at different heart rates can often provide your doctor with information to help the ablation. This study will involve an additional period of pacing at different heart rates, during which the electrical response is measured in different areas around the ventricle. This will allow us to calculate areas of the ventricle, which the investigators new measure FF would predict to be the source of the VT. In the future this may then allow us to better identify patients who are at risk of VT, and to better locate the area that needs to be ablated.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
London、英国、SE1 7EH
- Guys and St Thomas' NHS Trust
-
-
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:
- Age 18 or above, and capable of giving informed consent
- Scheduled for a clinically indicated cardiac ablation for the treatment of ventricular tachycardia
Exclusion Criteria:
- Moderate or severe aortic stenosis or mitral stenosis
- Active infection
- Presence of thrombus, cardiac tumour, interatrial Baffle patch (a specific form of congenital cardiac surgery) or prior septal occluder device
- Subjects who cannot be anticoagulated of infused with heparinized saline
- A history of heparin induced thrombocytopenia
- Pregnant or actively breast feeding
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 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:Ventricular Tachycardia (VT)
Patients with VT will undergo a clinically indicated ablation of their VT
|
During sinus rhythm these patients will undergo a simple pacing protocol to allow us to calculate FF, which is an area we would predict is mod likely to be the origin of their VT.
|
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 |
---|---|---|
Fibrillatory Factor
大体时间:18 months
|
To identify the proportion of clinical VT circuits which could be predicted during sinus rhythm from the calculation of fibrillation factor.
The number of FF derived VT exit points which are successfully predicted blindly by the investigators (using the clinically derived VT exit point based on electrophysiology assessment and ablation) will be the primary endpoint.
|
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Real-time fibrillatory factor
大体时间:18 months
|
Having established that fibrillatory factor (FF) can predict VT circuits we will then develop our software further so that we can calculate FF in real-time.
This will then be used in further research studies to guide invasive mapping.
|
18 months
|
合作者和调查者
调查人员
- 首席研究员:Jaswinder Gill, MD、Guy's and St Thomas' NHS Trust
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
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
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.