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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Manav Sohal, Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01665131
First Posted: August 15, 2012
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
  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: 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

Further study details as provided by Manav Sohal, Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Length of hospital stay

Secondary Outcome Measures:
  • 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.


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

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 Submitted: August 10, 2012
First Posted: August 15, 2012
Last Update Posted: August 15, 2012
Last Verified: August 2012