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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Guy's and St Thomas' NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01665131
First received: August 10, 2012
Last updated: August 13, 2012
Last verified: August 2012
  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

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

Primary Outcome Measures:
  • Length of hospital stay [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 July 20, 2014