CIED-related InfectionsNCT07210801
CIED Implantation Technique at Assiut University Heart Hospital in Relation to ESC Guidelines
An observational study of CIED-related Infections and CIED Implantation, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIED-related Infections, CIED Implantation
- What is being tested?
- CIEDimplantation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Nov 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study will involve adult patients (≥18 years) receiving CIED for standard arrhythmic, conduction system diseases or heart failure indications over a period of two years,
Who may be able to join
- All addult patients (≥18 years) referred foran indicatedCIED implantation at Assiut University Heart Hospital
Who cannot join
- Previous implantation of CIED implantation
- General contraindications of CIED
- Patient refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Salaheldeen Sayed Atta contact
About this study
Official title: Magnitude of Alignment With ESC Guidelines in Implantation Techniques of Cardiac Implantable Electronic Devices and Its Impact on Clinical Outcomes
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).
Read the 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
- Being tested
- CIEDimplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIEDimplantationDevice
Compare current procedural CIED practice at AUHH to recent ESC guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of procedure-related early complications (composite)
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
Measured: 30 day
Secondary outcomes (1)
Incidence of late complications after pacemaker implantation
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CIED-related InfectionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Nagaty Ayoup Qods, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210801
- Sponsor's protocol ID
- CIED Implantation Technique
- Status last verified
- Oct 2025
- First submitted
- 18 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15149441Da 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.
PubMed 10763187Kranick 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.
PubMed 35816293
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnitude of Alignment With ESC Guidelines in Implantation Techniques of Cardiac Implantable Electronic Devices and Its Impact on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07210801
- Acronym / sponsor ID
- CIED Implantation Technique
- Conditions
- CIED-related Infections, CIED Implantation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study will involve adult patients (≥18 years) receiving CIED for standard arrhythmic, conduction system diseases or heart failure indications over a period of two years,
Key inclusion criteria (1 listed)
- All addult patients (≥18 years) referred foran indicatedCIED implantation at Assiut University Heart Hospital
Key exclusion criteria (3 listed)
- Previous implantation of CIED implantation
- General contraindications of CIED
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIEDimplantationCompare current procedural CIED practice at AUHH to recent ESC guidelines. | Device | – |
Primary outcome
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
1 secondary outcome
Incidence of late complications after pacemaker implantation
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Results publication: PubMed 15149441Hayes 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.
- Results publication: PubMed 10763187Da 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.
- Results publication: PubMed 35816293Kranick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salaheldeen Sayed Atta contact
Questions about this trial
What is this clinical trial studying?
An observational study of CIED-related Infections and CIED Implantation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mina Nagaty Ayoup (+201018512887, menanagati50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of procedure-related early complications (composite) (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210801, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.