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NCT Number: NCT07530107

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

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.

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Key information

Conditions

Cardiac Implantable Electronic Device (CIED)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major clinical adverse outcomes

    Time frame: 1 year and 5 years follow up

    Cardiovascular mortality

  2. Major clinical adverse outcomes

    Time frame: 1 year and 5 years follow up

    cardiovascular rehospitalization

  3. Major clinical adverse outcomes

    Time frame: 1 year and 5 years follow up

    all-cause mortality

Secondary outcomes

  1. need of re-implantation of CIED for patients who underwent TLE

    Time frame: discharge, 1 and 5 years

    Eventual re-implantation after TLE, during the sane or a following hospitalization.

    Timing between TLE and re-implantation

Study contacts

Contact information is provided by the study sponsor or research team.

SImone Gulletta, MD

CONTACT

[email protected]

02 2643 7484

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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