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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890461
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
Samir Saba, University of Pittsburgh

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
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:

  1. Ischemia detection
  2. Myocardial Infarction detection
  3. Electrolyte abnormalities detection
  4. Assessment of effect of medications
  5. Improved rhythm discrimination

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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 : November 2007
Actual Primary Completion Date : February 8, 2017
Actual Study Completion Date : February 8, 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be identified by their cardiologist who is also an investigator on this study at the time they are evaluated for an ICD implantation. Once it has been determined during the course of the patient's regular clinical care that he or she requires an ICD, they will be approached for enrollment into the study by the physician investigator and the clinical research coordinator.

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890461

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United States, Pennsylvania
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Samir F Saba, MD University of Pittsburgh
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Responsible Party: Samir Saba, Director, Cardiac Electrophysiology, UPMC, University of Pittsburgh Identifier: NCT00890461    
Other Study ID Numbers: PRO07080211
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by Samir Saba, University of Pittsburgh: