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Clinical Trials/NCT01665131
NCT01665131
Unknown
N/A

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

Guy's and St Thomas' NHS Foundation Trust0 sites50 target enrollmentNovember 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Use of Subcutaneous ICDs Following Infection
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Enrollment
50
Primary Endpoint
Length of hospital stay
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
November 2015
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manav Sohal

Clinical Research Fellow

Guy's and St Thomas' NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • Patients fulfilling conventional criteria for ICD extraction and who require implantation of a further ICD without a need for pacing.

Exclusion Criteria

  • Indication for anti-bradycardia pacing or cardiac resynchronisation therapy
  • Life expectancy \< 1 year
  • Need for intravenous inotropes
  • Pregnancy

Outcomes

Primary Outcomes

Length of hospital stay

Secondary Outcomes

  • Rate of ICD infection(1 year)

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