CIEDimplantation
DeviceCompare current procedural CIED practice at AUHH to recent ESC guidelines.
NCT Number: NCT07210801
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Compare current procedural CIED practice at AUHH to recent ESC guidelines.
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
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.
Contact information is provided by the study sponsor or research team.
Mina Nagaty Ayoup
CONTACT
Salaheldeen Sayed Atta
CONTACT
Assiut University
Other
Magnitude of Alignment With ESC Guidelines in Implantation Techniques of Cardiac Implantable Electronic Devices and Its Impact on Clinical Outcomes
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