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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399412
• Other study ID #: DN-05291
• Status: Completed
• Phase: N/A
• First received: November 10, 2006
• Last updated: February 14, 2017
• Start date: November 2006
• Est. completion date: December 2007

Study information

• Verified date: October 2009
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronisation
• Heart Failure
• Long QT Syndrome
• Syndrome
• Wide QRS Complexes

Intervention

Device:
• subcutaneous ICD

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital NHS Trust	Papworth Everard	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom,