Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- -Rate and time of onset of high degree or complete AVB
研究概览
简要总结
The purpose of this study is to determine the incidence and predictors of high degree or complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve implantation (TAVI) and to evaluate the usefulness of the Reveal LINQ® insertable Cardiac Monitor (ICM) (Medtronic, Inc., Minneapolis, USA) for the detection of significant arrhythmias in patients with NOP-LBBB following TAVI.
详细描述
This is a prospective observational study including patients undergoing TAVI with either self- or balloon-expandable valves. After the procedure, patients will be on ECG monitoring during the hospitalization period (or at least 72 hours), and an ECG will be performed daily until hospital discharge in all patients. Patients with new-onset persistent LBBB at hospital discharge (new-onset LBBB of a duration of at least 48 h which persists at hospital discharge, at least 3 days and up to 15 days after the procedure) will receive an implantable loop recorder Reveal ICM LINQ®, which will be implanted subcutaneously to record adequate QRS complexes and P waves. The patients will be followed in outpatient clinic visits at 1, 12, 24 and 36 months after TAVR, or if symptoms suggestive of cardiac origin or relevant arrhythmic events occur. The device will be manually interrogated in each visit. Phone contacts will be also carried out every three months.
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
- 是
入选标准
- •Patients undergoing TAVI with either balloon or self-expandable valves who develop new-onset LBBB persistent at hospital discharge, at least 3 days after the procedure
排除标准
- •Failure to provide informed consent
- •Baseline pacemaker/defibrillator or pacemaker/defibrillator implanted during the hospitalization period following the TAVI procedure
- •Pre-existing complete LBBB
- •Patients with a life-expectancy of less than 2 years
结局指标
主要结局
-Rate and time of onset of high degree or complete AVB
时间窗: 1Year
-Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event
时间窗: 1 Year
次要结局
- -Rate of high degree or complete AVB(36-month follow-up)
- -Rate of new atrial fibrillation or ventricular arrhythmias(Within the first 3 years following TAVI procedure)
- -Changes in left ventricular function and mitral regurgitation over time(Within the first 3 years following TAVI procedure)
- -Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI(Within the first 3 years following TAVI procedure)
- -Rate of high degree or complete of AVB(6-month follow-up)
- -Rate of high degree or complete of AVB(Within the first month after TAVI procedure)
- -Rate of high degree or complete AVB(24-month follow-up)
研究者
Josep Rodes-Cabau
MD
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec