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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00890461

Collaborator

(none)

Enrollment

Locations

111.3

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
ICD	Radiation: CT scan of the chest without contrast

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Feb 8, 2017

Actual Study Completion Date :

Feb 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Defibrillator The subject population will be obtained by approaching the Principal and Co- Investigators' patients who have been referred for ICD implantation or who already have an ICD. This population ranges in age from 18 years on, and includes both males and females. A maximum of 50 subjects will be enrolled in this study.	Radiation: CT scan of the chest without contrast 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

Arm

Intervention/Treatment

Defibrillator

The subject population will be obtained by approaching the Principal and Co- Investigators' patients who have been referred for ICD implantation or who already have an ICD. This population ranges in age from 18 years on, and includes both males and females. A maximum of 50 subjects will be enrolled in this study.

Radiation: CT scan of the chest without contrast

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Presbyterian	Pittsburgh	Pennsylvania	United States	15213
2	UPMC Shadyside	Pittsburgh	Pennsylvania	United States	15232

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator: Samir F Saba, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samir Saba, Director, Cardiac Electrophysiology, UPMC, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00890461

Other Study ID Numbers:

PRO07080211

First Posted:

Apr 29, 2009

Last Update Posted:

May 3, 2017

Last Verified:

May 1, 2017

Keywords provided by Samir Saba, Director, Cardiac Electrophysiology, UPMC, University of Pittsburgh

ECG

ICD

Study Results

No Results Posted as of May 3, 2017