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

NCT ID: NCT01665131

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Use of Subcutaneous ICDs Following Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subcutaneous ICD group

Group Type EXPERIMENTAL

Cameron Health S-ICD SQ-RX

Intervention Type DEVICE

Interventions

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Cameron Health S-ICD SQ-RX

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Manav Sohal

Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher A Rinaldi, MD

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Other Identifiers

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SUBTRACT 1

Identifier Type: -

Identifier Source: org_study_id