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

ConditionCardiac Implantable Electronic Device (CIED)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Ospedale San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Lack of active status of follow-up

Trial population

patients underwent TLE for lead and pocket infection

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Ospedale San Raffaele

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: