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临床试验/NCT07414485
NCT07414485已完成不适用

A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2025年9月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
209
试验地点
1
主要终点
The incidence of severe delayed conduction disturbances occurring at 3 months in patients according to the presence or absence of risk criteria

研究概览

简要总结

Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited. The research team hypothesized that a rationalized strategy combining ECG findings with simple pre-procedural computed tomography (CT), derived criteria and implantation depth of the device, could improve risk stratification, reduce unnecessary pacemaker implantation (PPI) and preserve patient safety.

The investigator conducted a retrospective, multicenter study including 209 consecutive participants who underwent TAVR between February 2023 and September 2024 who were free from permanent pacemaker implantation at discharge. The investigator evaluated the performance of an ECG-based risk stratification algorithm previously described associated with pre-procedural CT parameters, including (membranous septum length, extent of valvular and subvalvular calcifications) and implantation depth. The primary endpoint was the incidence of severe delayed conduction disturbances (including high-grade or complete atrioventricular block, severe or symptomatic bradycardia requiring Permanent Pacemaker Implantation (PPI)) occurring at 3 months in patients according to the presence or absence of risk criteria defined by the algorithm. Secondary endpoints included the algorithm's positive and negative predictive values, assessment of non-syncopal conduction disorders, impact on post-procedural intensive care admission, timing of delayed conduction disturbances, delayed elective pacemaker indications, all-cause and cardiovascular mortality, and cardiac-related rehospitalizations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Any patient aged over 18 years
  • underwent TAVI, regardless of the access route and valve type
  • discharged from the hospital without a pacemaker

排除标准

  • Patients with a pre-existing pacemaker prior to TAVI

研究组 & 干预措施

Participants discharged after TAVI without permanent pacemaker

Participants discharged after TAVI without permanent pacemaker, not meeting any algorithm-defined risk criteria. ECG at baseline/post-procedure shows no qualifying conduction abnormality, and pre-procedural CT shows no high-risk anatomic features (e.g., membranous septum ≥ 6 mm and no high-risk valvular/LVOT ( left ventricular outflow tract) calcifications). Procedural characteristics (e.g., implantation depth) are not in the high-risk range. Follow-up according to standard of care at ~1 and ~3 months.

干预措施: retrospective health data collection (Other)

结局指标

主要结局

The incidence of severe delayed conduction disturbances occurring at 3 months in patients according to the presence or absence of risk criteria

时间窗: From hospital discharge (index TAVI) to 3 months post-procedure between February 2023 and September 2024

Percentage of participants discharged without a permanent pacemaker who develop a severe delayed conduction disturbance within 3 months, defined as high-grade AV (atrioventricular) block or severe/symptomatic bradyarrhythmia (e.g., sinus node dysfunction or atrial fibrillation (AF) with ventricular rate \<40 bpm) requiring therapeutic intervention (medication change, unplanned hospitalization, temporary or permanent pacemaker). Events are ascertained from ECGs/clinical assessments/records at routine \~1- and \~3-month follow-up and reported overall and stratified by the protocol-defined risk algorithm (ECG, cardiac CT anatomy-including membranous septum length and valvular/LVOT calcifications-and implantation depth).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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