Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Presence of rhythm disorders
研究概览
简要总结
Investigator-initiated, prospective, multicentre registry, whose objectives are: 1/ to evaluate the incidence of conduction defects and the need of pacemaker implantation post-procedure, at discharge, at 30 days and at 1 year post Myval transcatheter heart valve deployment, and 2/ To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve.
Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve that meet all inclusion criteria and any exclusion criteria will be able to participate in this study if they sign the informed consent. Electrocardiogram, echocardiogram and computed tomography will be performed to patients at different time points (Baseline, post-procedure, discharge, 30 days and 1 year post procedure) and their parameters will be added into a dedicated REDCAP database.
详细描述
Study Design: Investigator-initiated, prospective, multicentre registry. Study Phase: Phase IV.
Study Objectives:
- To evaluate the incidence of conduction defects and the need of pacemaker implantation post-procedure, at discharge, at 30 days and at 1 year post Myval transcatheter heart valve deployment.
- To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve.
Description of the study protocol:
- Patients meeting the inclusion and exclusion criteria will be enrolled after taking informed consent. The baseline data and electrocardiogram (ECG), echocardiogram and computed tomography parameters will be added into a dedicated REDCAP database.
- TAVR will be performed as per the standard procedure using Myval Transcatheter Heart Valve.
- The ECG parameters post procedure, at discharge, at 30 days and at 1 year post-procedure will be noted using the REDCAP database.
- Based on these ECG parameters, analysis will be done to look for mean variations of PR and QRS segments, atrio-ventricular block, bundle branch block or need for pacemaker from baseline to post-procedure, at discharge, at 30 days and at 1 year post procedure.
- Echocardiogram parameters at 30 days (optional) and at 1 year post procedure will be noted using the REDCAP database.
- Statistical analysis will be done using IBM SPSS Statistics and R software.
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
- •Adult patients (over 18 years of age)
- •Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.
排除标准
- •Patients with pre-existing permanent pacemaker.
- •Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.
结局指标
主要结局
Presence of rhythm disorders
时间窗: 30 days
Presence of any of the following conduction defects detected in 12-lead ECG: 1. Atrial Fibrillation 2. Pacemarker 3. Left bundle branch block 4. Right bundle branch block 6) 1st degree AVB 7) Other conduction disturbances
次要结局
- Presence of rhythm disorders(Postprocedural, 7 days, 1 year)
- Duration of PR interval(Postprocedural, 7 days, 30 days, 1 year)
- Duration of QRS complex(Postprocedural, 7 days, 30 days, 1 year)
研究者
Ignacio J. Amat Santos
Coordinator of Interventional Cardiology Unit
Hospital Clínico Universitario de Valladolid