Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Premature Ventricular Contraction (PVC) Response at 12-Month Follow-up
研究概览
简要总结
The TAVR-ELECTRO Registry (Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement) is a single-center, observational cohort study designed to systematically evaluate the occurrence, temporal evolution, and determinants of cardiac arrhythmias following transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.
This registry retrospectively enrolls consecutive patients undergoing TAVR at Fuwai Hospital, Chinese Academy of Medical Sciences, and collects comprehensive clinical, echocardiographic, electrocardiographic, and procedural data. Particular emphasis is placed on post-procedural electrophysiological outcomes, including ventricular arrhythmias, atrial arrhythmias, and conduction disturbances. Serial rhythm assessments using standard electrocardiography and ambulatory electrocardiographic monitoring are performed during follow-up to characterize arrhythmic burden and its dynamic changes over time.
The primary objective of the TAVR-ELECTRO Registry is to identify clinical, haemodynamic, and procedural factors associated with post-TAVR arrhythmic outcomes and recovery patterns, thereby improving the understanding of electrophysiological remodeling after TAVR and informing post-procedural risk stratification and management strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •Age ≥18 years at the time of transcatheter aortic valve replacement (TAVR). Diagnosis of severe aortic stenosis based on current guideline-recommended echocardiographic criteria.
- •Undergoing transcatheter aortic valve replacement (TAVR) as part of routine clinical care.
- •Availability of baseline electrocardiographic assessment, including ambulatory electrocardiographic monitoring for evaluation of premature ventricular contraction (PVC) burden.
- •Completion of post-procedural rhythm follow-up, including ambulatory electrocardiographic monitoring at 12 months after TAVR.
- •Ability to provide informed consent or availability of legally authorized consent, as required by the institutional review board.
排除标准
- •Absence of premature ventricular contractions at baseline (PVC burden = 0), as PVC response cannot be meaningfully assessed in this population.
- •Presence of a permanent pacemaker or implantable cardioverter-defibrillator prior to TAVR.
- •Receipt of catheter ablation for atrial or ventricular arrhythmias before TAVR or during the follow-up period.
- •Death occurring during the index hospitalization or before completion of rhythm follow-up.
- •Inability to complete scheduled electrocardiographic or ambulatory rhythm assessments during follow-up.
- •Missing or incomplete key electrocardiographic, echocardiographic, or follow-up data required for outcome assessment.
结局指标
主要结局
Premature Ventricular Contraction (PVC) Response at 12-Month Follow-up
时间窗: Baseline to 12 months after transcatheter aortic valve replacement (TAVR)
PVC response is defined as a reduction of ≥50% in premature ventricular contraction burden at 12 months compared with baseline. PVC burden is quantified as the total number of premature ventricular contractions per 24 hours, assessed by 24-hour ambulatory electrocardiographic monitoring. Patients without detectable PVCs at baseline are excluded from the primary responder analysis.
次要结局
未报告次要终点
研究者
Pan Xiangbin
Professor
Chinese Academy of Medical Sciences, Fuwai Hospital