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

NCT07530107 | Not Yet Recruiting

• 1 other identifier: CIED EXTRACTION
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Implantable Electronic Device (CIED)

Outcome Measures

Primary Outcomes (3)

• Major clinical adverse outcomes

  Cardiovascular mortality

  1 year and 5 years follow up

• Major clinical adverse outcomes

  cardiovascular rehospitalization

  1 year and 5 years follow up

• Major clinical adverse outcomes

  all-cause mortality

  1 year and 5 years follow up

Secondary Outcomes (1)

• need of re-implantation of CIED for patients who underwent TLE

  discharge, 1 and 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients underwent TLE for lead and pocket infection

You may qualify if:

• 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.

You may not qualify if:

• Lack of active status of follow-up

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Related Publications (4)

• 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;171(20):1821-8. doi:10.1001/archinternmed.2011.441 10. Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, et al. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States: 1993 to 2008. J Am Coll Cardiol. 2011;58(10):1001-6. doi:10.1016/j.jacc.2011.04.033

  BACKGROUND

• 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

  BACKGROUND

• Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol. 2012;5(2):252-7. doi:10.1161/CIRCEP.111.967638

  BACKGROUND

• 1. Bongiorni MG, Kennergren C, Butter C, Deharo JC, Kutarski A, Rinaldi CA, et al. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) registry of transvenous lead extraction outcomes. Eur Heart J. 2017;38(40):2995-3005. doi:10.1093/eurheartj/ehx080

  BACKGROUND

Central Study Contacts

SImone Gulletta, MD

CONTACT

02 2643 7484; gulletta.simone@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04