ECG Signal Collection From Long QT Syndrome, Wide QRS Complexes, Heart Failure, and Cardiac Resynchronization Patients

NCT ID: NCT00399412

Last Updated: 2017-02-16

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

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Long QT Syndrome Wide QRS Complexes Heart Failure Cardiac Resynchronisation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LQTS

Long QT syndrome

subcutaneous ICD

Intervention Type DEVICE

HF

Heart Failure

subcutaneous ICD

Intervention Type DEVICE

CRT

Cardiac Resynchronization Therapy

subcutaneous ICD

Intervention Type DEVICE

Wide QRS

QRS \> 120 milliseconds

subcutaneous ICD

Intervention Type DEVICE

Interventions

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subcutaneous ICD

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew A Grace, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Papworth Hospital NHS Trust

Locations

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Papworth Hospital NHS Trust

Papworth Everard, Cambridge, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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DN-05291

Identifier Type: -

Identifier Source: org_study_id

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