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临床试验/NCT07210801
NCT07210801尚未招募不适用

Magnitude of Alignment With ESC Guidelines in Implantation Techniques of Cardiac Implantable Electronic Devices and Its Impact on Clinical Outcomes

Assiut University0 个研究点目标入组 200 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Incidence of procedure-related early complications (composite)

研究概览

简要总结

This prospective observational cohort study will evaluate the extent to which cardiac implantable electronic device (CIED) implantation techniques at Assiut University Heart Hospital (AUHH) align with the evidence-based recommendations of the European Society of Cardiology (ESC).

详细描述

There is a huge and growing body of evidence demonstrating the importance of cardiac implantable electronic devices (CIEDs) in improving quality of life and survival among specific groups of patients with heart disease. This has led to an increasing number of implanted CIEDs, with approximately 1.2-1.4 million procedures performed annually worldwide. Over the years, advancements in device technology and implantation techniques have significantly improved patient outcomes and device longevity.

However, variations in implantation practices persist across different centers due to differences in training, available resources, and institutional protocols. The European Society of Cardiology (ESC) has established evidence-based guidelines outlining the optimal technique for CIED implantation, aiming to standardize practices and minimize procedure-related complications. These guidelines cover various aspects of the implantation process, including pre-procedural assessment, choice of venous access, lead positioning, infection prevention strategies, and post-implantation follow-up.

At Assiut University Heart Hospital, CIED implantation is routinely performed; however, the extent to which current practice aligns with the ESC-recommended optimal technique remains unclear. Understanding this alignment is crucial, as deviations from best practices may contribute to avoidable early complications, suboptimal device function, or reduced patient satisfaction.

This study aims to compare the current pacemaker implantation technique utilized at Assiut University Heart Hospital with the optimal implantation approach outlined in the latest ESC guidelines. Furthermore, it seeks to assess whether discrepancies or variations in CIED implantation techniques translate into differences in outcomes and complication rates. Assessing the degree of adherence to international guidelines by identifying gaps and areas for improvement may contribute to enhancing procedural quality, efficiency, patient safety, and clinical outcomes.

研究设计

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

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

  • All addult patients (≥18 years) referred foran indicatedCIED implantation at Assiut University Heart Hospital

排除标准

  • Previous implantation of CIED implantation
  • General contraindications of CIED
  • Patient refusal

结局指标

主要结局

Incidence of procedure-related early complications (composite)

时间窗: 30 day

Percentage of patients who develop any of the following within 30 days after pacemaker implantation: hematoma requiring intervention, lead dislodgement requiring reintervention, pneumothorax requiring treatment, pocket or device-related infection requiring antibiotics or device removal, acute pacing failure or sensing abnormality requiring reintervention

次要结局

  • Incidence of late complications after pacemaker implantation(12 month)

研究者

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

Mina Nagaty Ayoup Qods

Doctor

Assiut University

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