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临床试验/NCT07739316
NCT07739316尚未招募不适用

Systematic Ambulatory ECG Monitoring Following TAVI: A Prospective Randomized Trial.

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval1 个研究点 分布在 1 个国家目标入组 754 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
754
试验地点
1
主要终点
Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)

研究概览

简要总结

This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of sudden death, symptomatic arrhythmic events, or stroke within 1 year compared with standard post-discharge care. Patients undergoing successful TAVI without permanent pacemaker implantation and presenting with at least one ECG conduction abnormality at hospital discharge will be randomized to receive either ambulatory ECG monitoring or standard follow-up. All participants will undergo routine clinical follow-up at 30 days and 1 year after TAVI.

详细描述

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite advances in transcatheter heart valve technology and procedural techniques, conduction disturbances remain among the most frequent complications following TAVI. High-grade atrioventricular block, complete heart block, and new-onset bundle branch block may occur after the procedure and can lead to delayed permanent pacemaker implantation or life-threatening arrhythmic events. The increasing adoption of minimalist TAVI pathways with hospital discharge within 24-72 hours raises concerns that clinically significant arrhythmias may develop after discharge and remain undetected.

Ambulatory electrocardiographic (ECG) monitoring provides continuous rhythm surveillance during daily activities and enables the early detection of both symptomatic and asymptomatic bradyarrhythmias and tachyarrhythmias. Previous observational studies have demonstrated that clinically significant bradyarrhythmias occur in approximately 5-10% of patients during the first weeks after TAVI, particularly among those with baseline or new-onset conduction abnormalities. Ambulatory ECG monitoring has also identified previously unrecognized atrial fibrillation, allowing timely initiation of anticoagulation therapy in patients at high risk of thromboembolic events.

Although several prospective studies have evaluated ambulatory ECG monitoring after TAVI, most have been observational and were designed primarily to describe the incidence of post-procedural arrhythmias rather than to assess their impact on clinical outcomes. Preliminary evidence from the RECORD pilot study suggested that systematic ambulatory ECG monitoring after hospital discharge was associated with earlier identification and treatment of clinically significant arrhythmias and a reduction in the composite of sudden death, symptomatic arrhythmic events, and stroke during 1-year follow-up, with the greatest benefit observed among patients with conduction abnormalities at hospital discharge.

This randomized trial has been designed to provide definitive evidence regarding the clinical value of systematic ambulatory ECG monitoring after TAVI in patients at increased risk of post-procedural conduction disturbances. The study will evaluate whether early detection and management of clinically significant arrhythmias can improve clinical outcomes during the year following the procedure.

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

入选标准

  • Age >18 years
  • Successful TAVI procedure.
  • Hospitalization discharge ≤72 hrs following the TAVI procedure.
  • Presence of at least 1 ECG abnormality at hospital discharge (QRS ≥120 ms OR PR ≥200 ms)

排除标准

  • Pacemaker implantation (pre- TAVI or during hospitalization after the procedure).
  • TAVI valve-in-valve procedure
  • Any complication or logistic reason precluding hospital discharge ≤72 hrs following the TAVI procedure.
  • Impossibility to obtain signed informed consent.

结局指标

主要结局

Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)

时间窗: Within the year following the TAVI procedure

Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.

次要结局

  • Incidence of PPI(1 year after TAVI)
  • Incidence of all-cause mortality(30 days after TAVI)
  • Incidence of sudden death(1 year after TAVI)
  • Incidence of symptomatic arrhythmias(1 year after TAVI)
  • Incidence of stroke(1 year after TAVI)
  • Incidence of PPI(30 days after TAVI)
  • Incidence of the combined endpoint (sudden death, symptomatic arrhythmias or stroke) at 30 days(30 days after TAVI)
  • Incidence of sudden death(30 days after TAVI)
  • Incidence of symptomatic arrhytmias(30 days after TAVI)
  • Incidence of stroke(30 days after TAVI)
  • Incidence of the combined endpoint (sudden death, symptomatic arrhythmias, stroke) according to patient sex(1 year after TAVI)
  • Percentage of ventricular pacing(1 year after TAVI)
  • Incidence of the combined endpoint of sudden death, symptomatic arrhythmias, or stroke) according to ECG abnormalities(1 year after TAVI)
  • Incidence of the combined endpoint according to baseline ECG abnormality type(1 year after TAVI)
  • Incidence of sudden death according to baseline ECG abnormality type(1 year after TAVI)
  • Incidence of symptomatic arrhythmias according to baseline ECG abnormality type(1 year after TAVI)
  • Incidence of stroke according to baseline ECG abnormality type(1 year after TAVI)
  • Incidence of the combined endpoint according to discharge ECG abnormality type(1 year after TAVI)
  • Incidence of sudden death according to discharge ECG abnormality type(1 year after TAVI)
  • Incidence of symptomatic arrhythmias according to discharge ECG abnormality type(1 year after TAVI)
  • Incidence of stroke according to discharge ECG abnormality type(1 year after TAVI)
  • Change in quality of life(Baseline to 1 year after TAVI)
  • Incidence of cardiovascular mortality(30 days after TAVI)
  • Incidence of all-cause mortality(1 year after TAVI)
  • Incidence of cardiovasculare mortality(1 year after TAVI)

研究者

发起方
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Rodes-Cabau

Principal Investigator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

研究点 (1)

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