Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation

The purpose of this study is to reconstruct a 12-lead electrocardiogram (ECG) from intracardiac (IC) electrograms (EGM) obtained from defibrillator devices (ICD). The purpose of such a reconstruction is to allow the use of IC EGM for diagnosis of clinical conditions for which ECG have historically been used, and to test the feasibility of a reconstruction technique for the standard 12-lead or extended electrocardiogram from electrical potentials obtained from inside a patient.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ICD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Presbyterian, Pittsburgh, Pennsylvania, United States

About this study

Reconstructing a 12-lead surface ECG from intracardiac EGM vectors of patients implanted with defibrillators can be of great value. It allows implantable devices that have thus far been used exclusively for arrhythmia detection and treatment, to be used for diagnostic purposes in similar ways as the ECG. The advantage of the reconstruction process is that it provides real-time continuous monitoring, which can be used for multiple purposes, including but not limited to:

Ischemia detection
Myocardial Infarction detection
Electrolyte abnormalities detection
Assessment of effect of medications
Improved rhythm discrimination

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects must be at least 18 years of age.
Subjects must be referred for ICD implantation or already have an ICD implanted..
Subjects must be willing to sign informed consent.

Exclusion criteria

Subject is unable or unwilling to sign informed consent.
Subject is pacemaker dependent.
Subject is pregnant as indicated by standard clinical procedures prior to implant.

Treatment and study plan

CT scan of the chest without contrast

Radiation

Patients consenting to participate in the study may also undergo a baseline CT scan of the cest without contrast to allow for the geometrical characterization of their intracardiac electrodes from the ICD system in relation to the position of the 12-lead surface ECG electrodes which would be applied to the chest prior to the CT scan. This scan involves a small amount of radiation, a dose of approximately 1 rem. For comparison, radiation workers are permitted, by federal regulation, a maximum annual radiation exposure of 20 rems to the most sensitive organs of their body.

Other names: CT scan, ECG, ICD

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2017
Study completion: 2017
First posted: Apr 29, 2009
Registry last updated: May 3, 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