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

NCT ID: NCT07210801

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-11-01

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.

Conditions

CIED-related Infections; CIED Implantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

CIEDimplantation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mina Nagaty Ayoup Qods

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mina Nagaty Ayoup

Role: CONTACT

menanagati50@gmail.com

+201018512887

Salaheldeen Sayed Atta

Role: CONTACT

+20 109 1318801

References

Hayes DL, Furman S. Cardiac pacing: how it started, where we are, where we are going. J Cardiovasc Electrophysiol. 2004 May;15(5):619-27. doi: 10.1046/j.1540-8167.2004.04088.x. No abstract available.

Reference Type: RESULT

PMID: 15149441 (View on PubMed)

Da Costa A, Kirkorian G, Isaaz K, Touboul P. [Secondary infections after pacemaker implantation]. Rev Med Interne. 2000 Mar;21(3):256-65. doi: 10.1016/s0248-8663(00)80045-4. French.

Reference Type: RESULT

PMID: 10763187 (View on PubMed)

Kranick S, Mishra N, Theertham A, Vo H, Hiltner E, Coromilas J, Kassotis J. A Survey of Antibiotic Use During Insertion of Cardiovascular Implantable Devices Among United States Implanters. Angiology. 2023 Apr;74(4):351-356. doi: 10.1177/00033197221114689. Epub 2022 Jul 11.

Reference Type: RESULT

PMID: 35816293 (View on PubMed)

Other Identifiers

CIED Implantation Technique

Identifier Type: -

Identifier Source: org_study_id