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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00399412
First Posted: November 14, 2006
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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
LQTS
Long QT syndrome
Device: subcutaneous ICD
HF
Heart Failure
Device: subcutaneous ICD
CRT
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.

  Eligibility

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.
Criteria

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
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


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

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00399412     History of Changes
Other Study ID Numbers: DN-05291
First Submitted: November 10, 2006
First Posted: November 14, 2006
Last Update Posted: February 16, 2017
Last Verified: October 2009

Keywords provided by Boston Scientific Corporation:
S-ICD
ICD
ECG signals
Resting

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