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

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ClinicalTrials.gov Identifier: NCT00399412
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief 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

Condition or disease Intervention/treatment
Long QT Syndrome Wide QRS Complexes Heart Failure Cardiac Resynchronisation Device: subcutaneous ICD

Detailed 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.

Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Further Research on Human Feasibility of a Subcutaneous Implantable Defibrillator (S-ICD)- ECG Signal Collections From Various Patient Groups Whilst Attending Outpatient Follow-up
Study Start Date : November 2006
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort Intervention/treatment
Long QT syndrome
Device: subcutaneous ICD
Heart Failure
Device: subcutaneous ICD
Cardiac Resynchronization Therapy
Device: subcutaneous ICD
Wide QRS
QRS > 120 milliseconds
Device: subcutaneous ICD

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399412

United Kingdom
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Andrew A Grace, MD PhD Papworth Hospital NHS Trust

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00399412     History of Changes
Other Study ID Numbers: DN-05291
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: October 2009

Keywords provided by Boston Scientific Corporation:
ECG signals

Additional relevant MeSH terms:
Heart Failure
Long QT Syndrome
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities