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

Completed

• Conditions: Heart Failure; Cardiac Resynchronisation; Wide QRS Complexes; Long QT Syndrome
• Interventions: Device: subcutaneous ICD

• Registration Number: NCT00399412
• Lead Sponsor: Boston Scientific Corporation

Brief 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

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 Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-10
• Study First Submitted QC: 2006-11-10
• Study First Posted: 2006-11-14
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-10
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HF	subcutaneous ICD	Heart Failure
CRT	subcutaneous ICD	Cardiac Resynchronization Therapy
LQTS	subcutaneous ICD	Long QT syndrome
Wide QRS	subcutaneous ICD	QRS \> 120 milliseconds

Trial Locations

Locations (1)

Papworth Hospital NHS Trust; 🇬🇧 Papworth Everard, Cambridge, United Kingdom