Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Composite of all-cause death and rehospitalization for any reason
研究概览
简要总结
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.
详细描述
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •All inclusion criteria must be met
- •Age ≥ 18 years and
- •Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and
- •Presence of at least one of the following conduction disorders and
- •Pre-procedural basal conduction disorder (e.g., right/left bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec.
- •De novo conduction disorder after TAVI (de novo bundle branch block) with QRS between 120-160 msec.
- •Clinical stability at 24 hours post-procedure and
- •Capacity to give informed consent.
排除标准
- •No exclusion criteria must be met
- •Immediate indication for permanent pacemaker following the procedure.
- •Persistent complete atrioventricular block.
- •QRS >160 msec and/or PR prolongation.
- •Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge.
- •Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system.
- •Life expectancy < 12 months due to non-cardiovascular comorbidity.
- •Refusal or inability to undergo outpatient follow-up.
- •Pregnant or breastfeeding.
研究组 & 干预措施
Early discharge (24 hours post-TAVI)
Patients will be discharged from the hospital 24 hours post-TAVI with PhysioMem PM 100 4G ambulatory monitoring system.
干预措施: PhysioMem PM 100 4G ambulatory monitoring system (Device)
Discharge according Standard Care
Patients will be discharged from the hospital according standard care
干预措施: Standard care (Behavioral)
结局指标
主要结局
Composite of all-cause death and rehospitalization for any reason
时间窗: 30 days
Proportion of patients with: * All cause of death * Rehospitalization for any reason
Clinically relevant arrhythmic event requiring a change in therapy
时间窗: 30 days
Proportion of patients with clinically relevant arrhythmic event requiring a change in therapy, defined as the occurrence of any of the following: * Cardiac conduction disorders * Clinically relevant tachyarrhythmias
次要结局
- All-cause death(30 days)
- All-cause death(12 months)
- Unscheduled hospital readmission for any reason(30 days)
- Unscheduled hospital readmission for any reason(12 months)
- Cardiovascular death(30 days)
- Cardiovascular death(12 months)
- Hospital readmission due to cardiovascular cause(30 days)
- Hospital readmission due to cardiovascular cause(12 months)
- Implantation of a permanent pacemaker(30 days)
- Implantation of a permanent pacemaker(12 months)
- High-degree atrioventricular block (II or III)(30 days)
- De novo or recurrent atrial fibrillation requiring a change in therapy(30 days)
- Time to pacemaker implantation or therapeutic change due to arrhythmia(30 days)
- Time to pacemaker implantation or therapeutic change due to arrhythmia(12 months)
- Resolution vs persistence of conduction disorders(72 hours)
- QRS evolution: transient, persistent, or normalisation(30 days)
- Remote monitoring(30 days)
- hospital length to of stay from TAVI to discharge(At discharge)
- Direct cost associated with stay and readmissions(12 Months)
- Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 days)
- Quality of life assessed using Kansas City Cardiomyopathy Questionnaire (KCCQ)(12 Months)