NCT00890461

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• ICD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2017-02-08
• Completion: 2017-02-08
• First posted: 2009-04-29
• Last updated: 2017-05-03

Locations

2 sites across 1 country: United States