Not Yet RecruitingNot Applicable

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

300 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Major clinical adverse outcomes

Timeframe: 1 year and 5 years follow up

Major clinical adverse outcomes

Timeframe: 1 year and 5 years follow up

Major clinical adverse outcomes

Timeframe: 1 year and 5 years follow up

Trial details

NCT IDNCT07530107

SponsorIRCCS Ospedale San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-01

Contact for this trial

SImone Gulletta, MD

02 2643 7484 gulletta.simone@hsr.it

View on ClinicalTrials.gov More Cardiac Implantable Electronic Device (CIED) trials