Observational, Retrospective, Single-center Study Aimed at Evaluating Long-term Outcomes Following Transvenous Lead Extraction of Infected Cardiac Implantable Electronic Devices.

Long Term Outcomes of Cardiac Implantable Electronic Device Infections and Transvenous Lead Extraction: a Single Center Retrospective

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07530107

Enrollment

300

Registered

2026-04-15

Start date

2026-05-01

Completion date

2027-01-01

Last updated

2026-04-15

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

Conditions

Cardiac Implantable Electronic Device (CIED)

Brief summary

The study aims to review the centre experience in previous 20 years to understand clinical course of patients underwent TLE for lead and pocket infection, to better understand prognosis, re-implant indication, timing and strategy, and long term outcomes.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients ≥ 18 years. * Patients who underwent explantation of a single-chamber, dual-chamber, or biventricular pacemaker, or an intracardiac defibrillator, due to pocket infection, lead-related infection, or endocarditis at San Raffaele Hospital between January 2004 and November 2020.

Exclusion criteria

* Lack of active status of follow-up

Design outcomes

Primary

Measure	Time frame	Description
Major clinical adverse outcomes	1 year and 5 years follow up	Cardiovascular mortality

Secondary

Measure	Time frame	Description
need of re-implantation of CIED for patients who underwent TLE	discharge, 1 and 5 years	Eventual re-implantation after TLE, during the sane or a following hospitalization. Timing between TLE and re-implantation

Contacts

CONTACTSImone Gulletta, MD

gulletta.simone@hsr.it02 2643 7484

Outcome results