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临床试验/NCT07065123
NCT07065123已完成不适用

Study on Atrioventricular and Bundle Branch Block Vulnerability Identified by Outcome-based Risk Modeling (the SAVIOR Study)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University0 个研究点目标入组 112 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
主要终点
Permanent Pacemaker Implantation Rate for High-Grade AVB (≥Mobitz II/3°) Post-TAVR (12-Lead ECG Confirmed)

研究概览

简要总结

This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis (AS). Analyzing 112 patients from Sun Yat-sen Memorial Hospital (2017-2024), the study incorporated clinical, electrocardiographic, and procedural variables to identify risk factors via logistic regression. A nomogram was constructed and validated internally (bootstrapping) and externally (temporal validation), with performance assessed using AUC, C-index, and calibration tests. The model aims to improve preoperative risk stratification and guide individualized management for TAVR-related conduction disturbances in this understudied population. Analyses were conducted in R 4.2.3 (significance: *p* < 0.05).

详细描述

In recent years, transcatheter aortic valve replacement (TAVR) has emerged as a minimally invasive surgical approach and has gradually become a standard treatment option for patients with moderate to severe aortic stenosis(AS), particularly those at high surgical risk or deemed ineligible for conventional surgery. TAVR has been widely adopted in clinical practice.

However, post-TAVR cardiac conduction disturbances are among the most frequently observed complications, particularly complete left bundle branch block (CLBBB) and high-degree atrioventricular block (AVB) requiring permanent pacemaker implantation (PPI). These complications are associated with an increased risk of heart failure and cardiac mortality. Identified risk factors include patient-specific characteristics, electrocardiographic features, intraoperative procedural techniques, and the type of device used.

Current research on post-TAVR conduction disorders predominantly focuses on Western populations. However, Chinese AS patients exhibit distinct clinical features-such as higher degrees of valve calcification and a higher prevalence of bicuspid aortic valves-which may lead to differences in risk factors for conduction abnormalities. Moreover, prior studies have largely focused on isolated risk factors rather than developing integrated models to quantify the risk of such complications. Against this backdrop, the purpose of this study is to address the knowledge gap in postoperative risk prediction for Chinese patients. By constructing a risk prediction model tailored to Chinese AS patients for post-TAVR cardiac conduction block, we aim to improve preoperative risk assessment and individualized clinical management, thereby providing actionable guidance for clinical decision-making.

This study included 112 aortic stenosis patients undergoing TAVR at Sun Yat-sen Memorial Hospital (2017-2024), divided into internal (2017-2022) and external (2023-2024) validation cohorts.

Data covered demographics, medical history, ECG, echocardiography, biomarkers, and valve parameters. Outcomes were permanent pacemaker implantation (PPI) ≤48h post-TAVR and complete left bundle branch block (CLBBB).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years old) with severe symptomatic aortic stenosis (AS) meeting 2021 ESC/EACTS Guidelines and Chinese Expert Consensus criteria (AVA <1.0 cm², or peak jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg)
  • Scheduled to undergo transcatheter aortic valve replacement (TAVR) in Sun Yat-Sen Memorial Hospital

排除标准

  • Pre-existing complete left bundle branch block (CLBBB) on baseline ECG
  • Patients with pre-existing permanent pacemaker implantation
  • Inability to comply with follow-up protocol

结局指标

主要结局

Permanent Pacemaker Implantation Rate for High-Grade AVB (≥Mobitz II/3°) Post-TAVR (12-Lead ECG Confirmed)

时间窗: 7 years

Number of participants requiring permanent pacemaker implantation (PPI) due to high-grade atrioventricular block (AVB; ≥2nd degree Mobitz II or 3rd degree) within 48 hours post-TAVR, as clinically indicated and confirmed by 12-lead ECG and cardiology consultation

Complete left bundle branch block rate post-TAVR (12-lead ECG confirmed)

时间窗: 7 years

Number of participants developing new complete left bundle branch block , as defined by standard ECG criteria (QRS duration ≥120ms with characteristic morphology), within 48 hours post-transcatheter aortic valve replacement.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingfeng Wang

Professor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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