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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Long QT Syndrome Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiac Resynchronisation Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Wide QRS Complexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Papworth Hospital NHS Trust

Papworth Everard, Cambridge, CB3 8RE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subcutaneous ICD

Device

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Nov 14, 2006
Registry last updated: Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed