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

This study is currently recruiting participants.
Verified August 2011 by University of Pittsburgh
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00890461
First received: April 28, 2009
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
ICD
 Radiation: CT scan of the chest without contrast

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 50
Study Start Date: November 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890461

Contacts
Contact: Samir F Saba, MD 412-647-6272 sabas@upmc.edu
Contact: Susan A Mularski, BS, RN 412-648-6024 mularskisa@upmc.edu

Locations
United States, Pennsylvania
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Susan A Mularski, BS     412-648-6024     mularskisa@upmc.edu    
Principal Investigator: Samir F. Saba, MD            
Sub-Investigator: Stuart Mendenhall, MD            
UPMC Shadyside Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Susan A Mularski, BS     412-648-6024     mularskisa@upmc.edu    
Principal Investigator: Samir F Saba, MD            
Sub-Investigator: Stuart G Mendenhall, MD            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Samir F Saba, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Samir Saba, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00890461     History of Changes
Other Study ID Numbers: PRO07080211
Study First Received: April 28, 2009
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
ECG
ICD

ClinicalTrials.gov processed this record on May 23, 2013