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

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Boston Scientific

Status

Completed

Conditions

Wide QRS Complexes
Long QT Syndrome
Heart Failure
Cardiac Resynchronisation

Treatments

Device: subcutaneous ICD

Study type

Observational

Funder types

Industry

Identifiers

NCT00399412
DN-05291

Details and patient eligibility

About

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

Full 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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

86 participants in 4 patient groups

LQTS
Description:
Long QT syndrome
Treatment:
Device: subcutaneous ICD
HF
Description:
Heart Failure
Treatment:
Device: subcutaneous ICD
CRT
Description:
Cardiac Resynchronization Therapy
Treatment:
Device: subcutaneous ICD
Wide QRS
Description:
QRS \> 120 milliseconds
Treatment:
Device: subcutaneous ICD

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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