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The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs

NCT01665131 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-08-15

No results posted yet for this study

Summary

Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high risk of sudden cardiac death. They are used to treat life threatening heart rhythm disorders. They have conventionally consisted of a generator sitting under the skin of the chest and leads which pass from veins in the collar bone region to the heart. Problems with these devices can necessitate extraction, with the commonest reason being infection. If extraction is required for infection then re-implantation is usually deferred for approximately one week whilst antibiotics are given so that the risk of infection of the new device can be minimised. This has considerable implications for healthcare resources. A new ICD has been developed that is entirely subcutaneous with no intravenous element. It is already in clinical use and is positioned remote from conventional ICD sites. With no intravenous element there is very little risk of infection in the blood affecting the new device. It is therefore likely to be possible to re-implant these devices immediately after extracting a conventional system. The aim of this research is to assess the outcome in patients re-implanted with this device immediately after conventional ICD system extraction. This data will be compared compared to those who have conventional systems re-implanted after the necessary delay.

Conditions

  • Use of Subcutaneous ICDs Following Infection

Interventions

DEVICE

Cameron Health S-ICD SQ-RX

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Christopher A Rinaldi, MD · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-11-30
Completion
2015-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01665131 on ClinicalTrials.gov