The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs (SUBTRACT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Use of Subcutaneous ICDs Following Infection |
Device: Cameron Health S-ICD SQ-RX |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs |
- Length of hospital stay [ Designated as safety issue: No ]
- Rate of ICD infection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Subcutaneous ICD group | Device: Cameron Health S-ICD SQ-RX |
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Manav Sohal, Clinical Research Fellow, Guy's and St Thomas' NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01665131 History of Changes |
| Other Study ID Numbers: | SUBTRACT 1 |
| Study First Received: | August 10, 2012 |
| Last Updated: | August 13, 2012 |
| Health Authority: | United Kingdom: National Health Service |
ClinicalTrials.gov processed this record on June 17, 2013