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

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ClinicalTrials.gov Identifier: NCT01665131
Recruitment Status : Unknown
Verified August 2012 by Manav Sohal, Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Use of Subcutaneous ICDs Following Infection Device: Cameron Health S-ICD SQ-RX

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs
Study Start Date : November 2012
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: Subcutaneous ICD group Device: Cameron Health S-ICD SQ-RX


Outcome Measures

Primary Outcome Measures :
  1. Length of hospital stay

Secondary Outcome Measures :
  1. Rate of ICD infection [ Time Frame: 1 year ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665131


Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Christopher A Rinaldi, MD Guy's and St Thomas' NHS Foundation Trust
More Information

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
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012