CClinicalTrials.gg
Sign In
Not yet recruitingNCT07530107Updated Apr 15, 2026

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

An observational study in Cardiac Implantable Electronic Device (CIED), sponsored by IRCCS Ospedale San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by IRCCS Ospedale San Raffaele · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Implantable Electronic Device (CIED)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients underwent TLE for lead and pocket infection

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

Exclusion Criteria:

  • Lack of active status of follow-up
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Major clinical adverse outcomes

    Cardiovascular mortality

    Time frame: 1 year and 5 years follow up

  2. Major clinical adverse outcomes

    cardiovascular rehospitalization

    Time frame: 1 year and 5 years follow up

  3. Major clinical adverse outcomes

    all-cause mortality

    Time frame: 1 year and 5 years follow up

Secondary outcomes

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

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

    Time frame: discharge, 1 and 5 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med. 2011 Nov 14;171(20):1821-8. doi: 10.1001/archinternmed.2011.441. Epub 2011 Sep 12. PubMed 21911623 ↗
  • Vaidya VR, Alraies MC, Kelli HM, Patel N, Nairooz R, Maher J, et al. Transvenous lead extraction: predictors of mortality and outcomes in over 10,000 procedures. Heart Rhythm. 2021;18(7):1099-1105. doi:10.1016/j.hrthm.2021.03.013
  • Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):252-7. doi: 10.1161/CIRCEP.111.965277. Epub 2012 Feb 23. PubMed 22362891 ↗
  • Bongiorni MG, Kennergren C, Butter C, Deharo JC, Kutarski A, Rinaldi CA, Romano SL, Maggioni AP, Andarala M, Auricchio A, Kuck KH, Blomstrom-Lundqvist C; ELECTRa Investigators. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes. Eur Heart J. 2017 Oct 21;38(40):2995-3005. doi: 10.1093/eurheartj/ehx080. PubMed 28369414 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07530107
Lead sponsor
IRCCS Ospedale San Raffaele
Responsible party
Simone Gulletta (Principal investigator, IRCCS Ospedale San Raffaele) — Principal investigator
First posted
Apr 15, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Apr 15, 2026

Study contacts

SImone Gulletta, MD
Contact
gulletta.simone@hsr.it
02 2643 7484

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

IRCCS Ospedale San Raffaele

Start the discussion