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

Study Overview
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Brief Summary
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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.

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

Conditions
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Use of Subcutaneous ICDs Following Infection

Intervention / Treatment
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* Device: Cameron Health S-ICD SQ-RX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subcutaneous ICD group<br> | Device: Cameron Health S-ICD SQ-RX<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ICD infection | To see what the infection rate of new implants is and to assess how this compares to published rates of infection when using the standard method. | 1 year |