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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00890461
Enrollment
42
Registered
2009-04-29
Start date
2007-11-30
Completion date
2017-02-08
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD

Keywords

ECG, ICD

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.

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

Interventions

RADIATIONCT 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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026