Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Total fluoroscopy time (minutes)
研究概览
简要总结
This study is investigating whether using ultrasound directly inside the heart during ablation of heart rhythm disorders in the ventricles can reduce radiation exposure for patients.
During an ablation, catheters are guided through the heart to treat the abnormal electrical signals. Usually, X-ray imaging (fluoroscopy) is used to see where the catheters are, which exposes both patients and hospital staff to radiation.
The study is randomized and controlled: half of the participants will have the ablation with ultrasound inside the heart, and the other half will have the standard ablation without ultrasound during the procedure. The main goal is to compare the amount of X-ray time used during the procedure. Secondary goals are to look at safety, effectiveness, and the total procedure time.
Patients with premature ventricular contractions or ventricular tachycardia can take part. A total of 70 people will be included, 35 in each group. Using ultrasound inside the heart makes it possible to see the catheters and heart structures directly, so many steps can be done without X-rays. This could make ablations safer and reduce radiation exposure.
The study is being carried out at Inselspital, Bern University Hospital, and at University Hospital Basel. All steps are standardized and data are collected carefully. The results will show whether ultrasound during ablations can significantly reduce radiation and make ablations more efficient and safer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 (≥18y) undergoing a premature ventricular contraction or ventricular tachycardia ablation.
排除标准
- •Origin of ventricular arrhythmia with high likelihood in the right ventricular outflow tract (left-bundle-inferior axis, >V4 transition precordially)
- •Primary epicardial ablation planned
- •Congenital heart disease
- •Presence of a mechanical tricuspid valve prosthesis
- •Unwilling or unable to comply fully with study procedures and followup
结局指标
主要结局
Total fluoroscopy time (minutes)
时间窗: Day 0 (during procedure)
Total fluoroscopy time (minutes) from the start to the end of the ablation procedure of ventricular arrhythmias
次要结局
- Dose area product(Day 0 (during procedure))
- Cumulative radiation dose(Day 0 (during procedure))
- Dose area product(Day 0 (during procedure))
- Cumulative radiation dose(Day 0 (during procedure))
- Total procedure time (minutes)(Day 0 (during procedure))
- Rate of acute procedural success(Day 0 (during procedure))
- Rate of sustained VT during follow-up(Day 0-90 after procedure)
- PVC reduction (%) during follow-up(Day 0-90 after procedure)