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

Further Research on Human Feasibility of a Subcutaneous Implantable Defibrillator (S-ICD)- ECG Signal Collections From Various Patient Groups Whilst Attending Outpatient Follow-up

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Long QT Syndrome; Wide QRS Complexes; Cardiac Resynchronisation
• Intervention / Treatment: 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
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge
    • Papworth Everard, Cambridge, United Kingdom, CB3 8RE
      • Papworth Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Andrew A Grace, MD PhD, Papworth Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: November 10, 2006
• First Submitted That Met QC Criteria: November 10, 2006
• First Posted (Estimate): November 14, 2006

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: ICD; Resting; S-ICD; ECG signals
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Failure; Syndrome; Long QT Syndrome
• Other Study ID Numbers: DN-05291