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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07210801
Enrollment
200
Registered
2025-10-07
Start date
2025-10-01
Completion date
2027-11-01
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CIED Implantation, CIED-related Infections

Brief 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.

Interventions

DEVICECIEDimplantation

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of procedure-related early complications (composite)30 dayPercentage 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

MeasureTime frameDescription
Incidence of late complications after pacemaker implantation12 monthNumber 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.

Contacts

Primary ContactMina Nagaty Ayoup
menanagati50@gmail.com+201018512887
Backup ContactSalaheldeen Sayed Atta
+20 109 1318801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026