Role of a Novel Implantable Loop Recorder in the Management of Premature Ventricular Contractions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Identification of unrecognized myocarditis
研究概览
简要总结
This prospective, observational study is a single center clinical registry of patients referred for management of symptomatic or asymptomatic Premature Ventricular Contractions (PVCs). Subjects will be followed through 12 months. The study will enroll approximately 50 patients.
详细描述
This study is intended to monitor patients presenting with Premature Ventricular Contractions (PVCs) and ventricular arrhythmias using implantable loop recorders (ILRs) from the time of their initial presentation of PVCs to assess for the incidence of all cardiac arrhythmias detected with long term monitoring in this population. It is also intended to evaluate for clinical, biomarker and radiological evidence of myocarditis in this cohort to understand association with incident arrhythmias and understand the role of implantable loop recorders (ILRs)in managing these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 > 18 years of age
- •Have a Medtronic LINQ II ILR
- •Willing and able to give written informed consent
排除标准
- •History of myocardial infarction
- •Significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or Computed tomography angiography (CTA).
- •History of cardiac arrest
- •With existing implantable defibrillators
- •Currently pregnant
结局指标
主要结局
Identification of unrecognized myocarditis
时间窗: 12 Months
Identification of unrecognized myocarditis in patients presenting PVCs with positive FDG-PET \[fluorodeoxyglucose (FDG)-positron emission tomography (PET)\] scanning.
Evaluation of efficacy of immunosuppressive therapy - LVEF improvement
时间窗: 12 Months
Evaluation of efficacy of immunosuppressive therapy in patients with NICM by documenting improvement in LVEF compared to their baseline LVEF.
Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce
时间窗: 12 Months
Evaluation of efficacy of immunosuppressive therapy in patients with NICM with PVCs in reducing PVC burden as compared to their baseline PVC burden.
Associated atrial and ventricular arrhythmias
时间窗: 12 Months
Assessing incidence of associated atrial and ventricular arrhythmias as detected with ILR recordings in patients with apparently idiopathic PVCs.
次要结局
未报告次要终点