Ventricular Mechanical Impact, Contraction Efficiency and Heart Function With Right Ventricular Pacing by MICRATMTPS. Comparison With Conventional RV Pacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Assessment and comparison of the mechanical impact of right ventricular pacing using the Micra TPS versus a conventional PM on the left ventricular function.
研究概览
简要总结
This prospective, un-blinded, randomized, noninferiority, single centre study with 12 month follow-up included patients who were scheduled for a single-chamber PM implant. Patients were 1:1 randomized to undergo the implantation of a conventional VVI pacing system (Medtronic, Advisa ADSR03) with a ventricular pacing lead (Medtronic, 5076-58) in the right ventricle (called 'conventional group') or to be implanted with a leadless Micra TPS (called 'Micra group').
The primary objective was to assess and compare the mechanical impact of right ventricular pacing using the Micra TPS versus a conventional PM on the left ventricular function.
详细描述
The primary endpoint was to assess the mechanical impact of the Micra TPS on the left ventricular function. The investigators measured the change of Global Longitudinal Strain (GLS) over one year after pacemaker implantation.
As secondary endpoint, the investigators studied the effect of the Micra TPS on the right ventricle using speckle tracking for 2-D myocardial motion estimation. The investigators also assessed conventionally the function of the right ventricle using tricuspid annular plane systolic excursion (TAPSE) in accordance with the guidelines of the European Association of Cardiovascular Imaging and American Society of Echocardiography. Evolution of clinical and biological parameters as NYHA (New York Heart Association) classification, '6 minutes 'walk distance and measurement of brain natriuretic peptide (NT-proBNP) test was also be performed at baseline and after one year follow-up.
Design
It was an interventional prospective not blinded randomized single centre study. The investigators randomized fifty patients into two groups (1:1 ratio) between May 2018 and December 2021:
Group 1 : 25 patients underwent the implantation of a conventional ventricular pacemaker (Medtronic) with placement of a ventricular lead Medtronic 5076-58 in the right ventricle.
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
- 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 with a Class I or II indication for single chamber pacemaker following international guidelines
排除标准
- •patients with previously implanted cardiac devices / mechanical valves that would interfere with the echocardiographic measurements
- •patients with inadequate image quality at baseline that prohibited the assessment of myocardial mechanics using echocardiography
- •patients with a left ventricular ejection fraction (LVEF) ≤40% at baseline
- •patients considered to have a pre-existing condition challenging/precluding the implant of a conventional pacemaker
- •patients who refused or were not able to provide written informed consent.
结局指标
主要结局
Assessment and comparison of the mechanical impact of right ventricular pacing using the Micra TPS versus a conventional PM on the left ventricular function.
时间窗: 1 year
The primary endpoints were the change in left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS)
次要结局
- Evolution of pacemaker performance(1 year)
- Evolution of the right ventricular, tricuspid valve and mitral valve function(1 year)
- Evolution of NT-pro-BNP(1 year)