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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00399412
Other study ID # DN-05291
Secondary ID
Status Completed
Phase N/A
First received November 10, 2006
Last updated February 14, 2017
Start date November 2006
Est. completion date December 2007

Study information

Verified date October 2009
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to collect surface electrograms from standard and several non-standard configurations in patients with long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS during a routine outpatient assessment. The ECGs collected will be used as test signals by the sponsor for the development of a subcutaneous implantable defibrillator


Description:

The objective of this study is to record standard ECG signals is each of the 4 patient populations together with signals from 4 non-standard surface positions when these patients attend the outpatient department for follow-up. The non-standard electrode positions mimic the positions of the subcutaneous electrodes of the subcutaneous implantable defibrillator (S-ICD) system in development by Cameron Health.

The collection of these signals will allow bench testing of the algorithms proposed for the S-ICD system. Additionally, it will allow a comparison of the response of different defibrillators to these same signals to asses how each would treat a particular rhythm.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients attending the outpatient for routine follow-up for their cardiac disease or to have an implanted device follow-up

Exclusion Criteria:

- Patients unable or unwilling to provide informed consent

- Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study

Study Design


Intervention

Device:
subcutaneous ICD


Locations

Country Name City State
United Kingdom Papworth Hospital NHS Trust Papworth Everard Cambridge

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

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