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NCT Number: NCT07210801

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CIEDimplantation

Device

Compare current procedural CIED practice at AUHH to recent ESC guidelines.

Primary outcomes

  1. Incidence of procedure-related early complications (composite)

    Time frame: 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

Secondary outcomes

  1. Incidence of late complications after pacemaker implantation

    Time frame: 12 month

    Number and percentage of patients who develop late device-related complications such as pocket erosion, late infection, venous thrombosis, or lead malfunction after 30 days and up to 12 months post-implantation.

Study contacts

Contact information is provided by the study sponsor or research team.

Mina Nagaty Ayoup

CONTACT

[email protected]

+201018512887

Salaheldeen Sayed Atta

CONTACT

+20 109 1318801

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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