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

This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: November 10, 2006
Last updated: February 14, 2017
Last verified: October 2009
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 Intervention
Long QT Syndrome Wide QRS Complexes Heart Failure Cardiac Resynchronisation Device: subcutaneous ICD

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Enrollment: 86
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Boston Scientific Corporation Identifier: NCT00399412     History of Changes
Other Study ID Numbers: DN-05291
Study First Received: November 10, 2006
Last Updated: February 14, 2017

Keywords provided by Boston Scientific Corporation:
ECG signals

Additional relevant MeSH terms:
Long QT Syndrome
Heart Failure
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities processed this record on September 20, 2017