NCT03458273Unknown不适用
Multi-center, Observational, Retrospective Comparison of the Feasibility, Safety, and Efficacy of Real Zero Fluoroscopy Versus Conventional Fluoroscopic Catheter Ablation With and Without 3D System Support: Propensity Matched Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Procedural success rates
研究概览
简要总结
A Retrospective Propensity Matched Study comparing:
- real zero fluoroscopy catheter ablation
- conventional fluoroscopy catheter ablation without 3D system
- conventional fluoroscopy catheter ablation with 3D system
详细描述
Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias.
The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who:
- underwent conventional fluoroscopy guided catheter ablation without 3D system (Ensite/Carto) support
- underwent conventional fluoroscopy guided catheter ablation with 3D system (Ensite/Carto) support
Covariates for matching will be:
- arrhythmia type
- age of a patient
- number of diagnostic catheters used during a procedure
- type of a diagnostic catheter used during a procedure]
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •right atrial tachycardia
- •right atrial premature complexes
- •right atrial AVRT/WPW
- •right ventricle tachycardia / right ventricle premature complexes
排除标准
- •left atrium arrhythmia
- •left ventricle arrhythmia
结局指标
主要结局
Procedural success rates
时间窗: 3 months
arrhythmia recurrence within 3 months since the index procedure
次要结局
- Fluoroscopy time(during procedure)
- Acute procedural success(10-30 minutes)
- Recurrence rate(6 months)
- Total procedure time(during procedure)
- Acute Complications rate(during procedure)
- The length of stay during the hospitalization(1 month)
- All Complications rate(6 months)
研究者
Maciej Wójcik, MD, PhD
Associate Professor
Medical University of Lublin
研究点 (3)
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