PASO - Automated Template Matching for PVC Ablation: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- PVC recurrence in Holter ECG
研究概览
简要总结
Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial. The Aim of this study is to evaluate the additional benefit of PASO template matching on PVC ablation procedure with regard to procedural parameters and outcome when compared with conventional pace mapping. A total of 144 pts will be randomised in a 1:1 fashion to PVC ablation guided by conventional pacemapping vs PVC ablation guided by PASO pacemapping. Patients will be follow up with Holter-ECG and TTE after 3 and 12 months.
详细描述
Introduction / Rationale Premature ventricular contractions (PVC) in the otherwise healthy heart are not associated with increased mortality in the absence of a short coupling interval or a compromised left ventricular function and do not require treatment if asymptomatic . Symptomatic idiopathic PVC or VT on the other hand can burden patients with recurring palpitations, dizziness, dyspnea and possibly syncope in cases of fast VT. A reversible decrease in left ventricular function as a result of a high PVC burden has been reported even in patients with no underlying cardiomyopathy . Radiofrequency Ablation (RFA) is a well-established method to treat idiopathic PVC and VT, and is associated with satisfying long-term results. Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial.
Aim of the study To evaluate the additional benefit of PASO template matching on PVC ablation procedure with regard to procedural parameters and outcome when compared with conventional pace mapping.
Hypothesis PASO guidance during PVC / VT ablation has a significant impact on outcome after catheter ablation of idiopathic PVC / VT.
Study design This study is planned as a two-center trial. All patients presenting for de novo ablation of idiopathic ventricular arrhythmia will be included and randomized in a 1:1 fashion in this open-label, two-center, randomized controlled trial.
In patients randomized to the PASO / intervention group pacemapping will be guided by automated template matching of the PASO module of CARTO3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients will be masked to treatment arm. Investigator performing statistical analysis and adjudicating outcomes will be masked to treatment arm
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Informed, written consent
- •ventricular arrhythmia (PVC or VT) with indication for CA
排除标准
- •Patients under guardianship or with mental disorders / disabilities
- •Polymorphic PVC / VT
- •ongoing myocardial ischaemia
- •pregnancy
- •valve replacement that prevents access to the suspected site of PVC origin
结局指标
主要结局
PVC recurrence in Holter ECG
时间窗: 12 weeks after ablation procedure
Assessment of PVC as % of total number heart beats in a 24 hours Holter ECG
次要结局
- Symptomatic recurrence(between 3 and 12 months after ablation)
- Procedural ablation parameters(From groin puncture to sheath removal)
- LV ejection fraction assessment (%)(between 3 months and 12 months after ablation)
- Procedure duration(From groin puncture to sheath removal)
- Prcedural fluoroscopy parameters(From groin puncture to sheath removal)