The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs
SUBTRACT
SUBTRACT
Sponsor study identifier
interventional
50
0 countries
N/A
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 10, 2012
Actual (reported)August 15, 2012
Actual (reported)November 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Length of hospital stay
Rate of ICD infection
1 year
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Christopher A Rinaldi, MD
Guy's and St Thomas' NHS Foundation Trust
First Submitted
August 10, 2012
First Posted
August 15, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 15, 2012
Record last verified: 2012-08
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Source: ClinicalTrials.gov.
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