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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:
Information provided by:
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT00399412
First received: November 10, 2006
Last updated: October 8, 2009
Last verified: October 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Cameron Health, Inc.:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399412

Locations
United Kingdom
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
Cameron Health, Inc.
Investigators
Principal Investigator: Andrew A Grace, MD PhD Papworth Hospital NHS Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399412     History of Changes
Other Study ID Numbers: DN-05291
Study First Received: November 10, 2006
Last Updated: October 8, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cameron Health, Inc.:
S-ICD
ICD
ECG signals
Resting

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

ClinicalTrials.gov processed this record on May 16, 2013