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

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.

Study Overview

• Status: Unknown
• Conditions: Use of Subcutaneous ICDs Following Infection
• Intervention / Treatment: Device: Cameron Health S-ICD SQ-RX

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subcutaneous ICD group	Device: Cameron Health S-ICD SQ-RX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Length of hospital stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ICD infection	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.	1 year

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Christopher A Rinaldi, MD, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: August 13, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: SUBTRACT 1