This trial is active, not recruiting.

Condition icd
Treatment ct scan of the chest without contrast
Sponsor University of Pittsburgh
Start date November 2007
End date December 2016
Trial size 50 participants
Trial identifier NCT00890461, PRO07080211


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.
ct scan of the chest without contrast CT scan
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation
Principal investigator Samir F Saba, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.