NCT07210801

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Oct 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Oct 2025Nov 2027

First Submitted

Initial submission to the registry

September 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

September 18, 2025

Last Update Submit

October 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    30 day

Secondary Outcomes (1)

  • Incidence of late complications after pacemaker implantation

    12 month

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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,

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

Central Study Contacts

Mina Nagaty Ayoup

CONTACT

Salaheldeen Sayed Atta

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 18, 2025

First Posted

October 7, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share