NCT07210801

CIED Implantation Technique at Assiut University Heart Hospital in Relation to ESC Guidelines

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• CIED-related Infections
• CIED Implantation

Interventions

Type	Name	Description
DEVICE	CIEDimplantation	Compare current procedural CIED practice at AUHH to recent ESC guidelines.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2027-11-01
• First posted: 2025-10-07
• Last updated: 2025-10-07