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
  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 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
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 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
Syndrome
Arrhythmias, Cardiac
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Disease
Heart Defects, Congenital
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014