Use of the Rhytmia System for Determining the Precise Location and Potential Mechanism of Premature Ventricular Contractions
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determining the surface of optimal pace map or activation map
研究概览
简要总结
This is a purely observational project and the objectives are to record and analyze the local potentials at the site of Premature Ventricular Contraction (VPC) focus through the Rhythmia system, ti determine the short and long-term success of the procedure and compare it to the existing literature about standard procedures, to highlight the advantages of the system compared to conventional mapping and to characterize optimal pace map or activation map as achieved by the Rhythmia system.
详细描述
This is a purely observational study. No special methodology choice, no comparison.
The study want to find the determination of precise location of the focus and mechanisms involved constitutes a challenge for conventional electrophysiology, even with tridimensional systems, because of the time needed for accurate delineation of the location (due to the sometimes unfrequent Ventricular Premature Beats (VPB)) and to the insufficient mapping density or inadequate signal characteristics. The Rhythmia system could allow better determination of the focus location in relation to the anatomical structures, especially with unfrequent VPB, because of the available high density mapping due to the number of closed high-resolution electrodes located on the Orion catheter. Better delineation of the true focus origin and of the mechanisms involved (automaticity vs re-entry) may be of useful help for better understanding and efficient therapy.
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 symptomatic monomorphic PVC with or without heart disease refractory to anti arrhythmic drugs
- •patients with dilated cardiomyopathy and altered Left Ventricular Ejection Fraction (LVEF) suspected to be causes by frequent monomorphic VPC
- •patients with malignant ventricular arrhythmias reproducibly induced by monomorphic PVC
排除标准
- •patients with non-symptomatic VPC and without cardiomyopathy
- •patients under 18 yo
- •pregnant women
- •patients with polymorphic PVC arising from clearly different areas
- •patient protected by the french law: guardianship and Trusteeship
结局指标
主要结局
Determining the surface of optimal pace map or activation map
时间窗: One year
To evaluate the area of isochronal earliest activation of PVC (Premature Ventricular Contraction), based on unipolar or bipolar activation : correlations will be made with the suspected endocardial or epicardial/intra-mural location of the focus. This technic may reduce the area of perfect pace-mapping and possibly more accurately locate the focus.
次要结局
- Characterize optimal pace map or activation map as achieved by the Rhythmia system(One year)
- Determine the short success of the procedure(One year)
- Record the local potentials at the site of PVC focus through the Rhythmia system(One year)
- Determine long-term success of the procedure and compare it to the existing(One year)