Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
研究概览
简要总结
Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.
Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).
This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 aged 18 years or older
- •Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI
- •New York Heart association classification ≥3 for cohort 3 and classification 1 or 2 for cohorts 1 and 2
- •Willing and able to provide signed written informed consent
- •No contra-indication for long-term monitoring (known allergy to adhesives)
排除标准
- •Prior cardiac surgery, including previous mitral valve intervention
- •Prior endovascular mitral valve repair (MitraClip)
- •Previous catheter ablation of ventricular arrhythmias
- •Patients not in sinus rhythm
- •Patients on anti-arrhythmic drugs but betablockers
- •Known alternative arrhythmic substrate, for example previous myocardial infarction
- •Known allergy to adhesives
研究组 & 干预措施
14 day monitoring
干预措施: 14-day rhythm monitoring (Diagnostic Test)
结局指标
主要结局
Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
时间窗: 14 days
Number of days with ≥ 1 nsVT, VT or VF episode
Number of days with high PVC-burden ≥5%
时间窗: 14 days
Number of days with a PVC-burden ≥5%
Day-to-day variation in percentage PVC burden
时间窗: 14 days
Day-to-day variation of the absolute number of PVC burden in percentage
Time to arrhythmic mitral valve prolapse detection
时间窗: 14 days
The number of days to reach the detection of arrhythmic mitral valve prolapse, defined as a PVC burden ≥ 5%, nsVT, VT or VF
次要结局
- Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI(14 days)
- Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI(14 days)
- Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography(14 days)
- Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography(14 days)