Comparison of Early Ambulatory Monitoring Strategy Versus Electrophysiological Study Approach in the Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Alive status with appropriate Pacemaker implantation/non-implantation
研究概览
简要总结
The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker implantation/non-implantation, at 12 months after randomization, in patients with New Onset Persistent Left Bundle Branch Block after Transcatheter Aortic Valve Implantation.
详细描述
This is a prospective, multicentric, randomized in parallel group, controlled, open labelled clinical study.
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After Transcatheter Aortic Valve Implantation, all consecutive patients presenting with new onset Left Bundle Branch Block will undergo in-hospital telemetry. In case of persistence (at least 48 hours) of a stable (i.e., no change in the last 24 hours) Left Bundle Branch Block > 150 ms, and in the absence of high grade Aortic Valve block or persistent prolonged PR interval > 240 ms, patients will be eligible for the study
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After written consent will be obtained, included patients will be randomized into two groups according to a 1:1 ratio:
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Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge. In this group, Pacemaker implantation will be decided, after discharge, on documented Electrocardiogram abnormalities obtained from the 1 month Electrocardiogram Ambulatory Monitoring. Any other clinically relevant therapeutic decision based on Electrocardiogram Ambulatory Monitoring will be taken or
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ElectroPhysiological Study for infra-hisian conduction evaluation. Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms
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Patients in both groups will be followed until the end of the first year after randomization. Follow-up visits will be scheduled in person at 1 and 12 months, and through telemedicine at 3 and 6 months. Appropriateness of Pacemaker implantation/non-implantation will be evaluated at each follow-up time
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In case of any occurrence of syncope, patients will be evaluated in person, by the principal investigator of each centre, to evaluate and manage the syncope as recommended by the European Society of Cardiology guidelines.
Patients will be followed-up according to current practice.
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
盲法说明
open labelled clinical study
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 who are 18 years or older and undergo Transcatheter Aortic Valve Implantation :
- •Presenting with New Onset Persistent Left Bundle Branch Block, defined as a new Left Bundle Branch Block >150 ms that persists at least two days after Transcatheter Aortic Valve Implantation and is stable
- •With an anticipated life expectancy >1 year
- •Who consent to participate to the study
排除标准
- •During in-hospital Electrocardiogram monitoring period, immediately after Transcatheter Aortic Valve Implantation and before inclusion:
- •Documented high grade Atrio Ventricular block (Atrio Ventricular block of a degree higher than Mobitz I)
- •Persistent PR interval prolongation > 240 ms
- •Occurrence of syncope or sudden cardiac death,
- •Identification of any indisputable criteria for Pacemaker implantation
- •Definitive Pacemaker implantation
- •Prior Pacemaker or Implantable Cardiac defibrillator
- •Indication for Cardiac Resynchronization Therapy or Implantable cardiac defibrillator
- •Pre-existing Left Bundle Branch Block or Right Bundle Branch Block
- •Pre-existing PR interval prolongation > 240 ms
- •Severe or moderate dementia, evaluated before Transcatheter Aortic Valve Implantation, defined as a Mini Mental State Examination < 15
- •Pregnancy or breastfeeding patient
- •No affiliation to a social security scheme
- •Adult under legal protection (trusteeship, guardianship).
结局指标
主要结局
Alive status with appropriate Pacemaker implantation/non-implantation
时间窗: 12 months
The primary endpoint of this study is the alive status with appropriate Pacemaker implantation/non-implantation, at 12 months after randomization. * Appropriate Pacemaker non-implantation: - Absence of syncope or sudden cardiac death in a non-implanted patient * Appropriate Pacemaker implantation: * Documented indisputable criteria for Pacemaker implantation * Absence of syncope or sudden cardiac death * Absence of upgrading procedure
次要结局
未报告次要终点