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

Completed

• Conditions: ICD
• Interventions: Radiation: CT scan of the chest without contrast

• Registration Number: NCT00890461
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2017-02-08
• Study Completion: 2017-02-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Defibrillator	CT scan of the chest without contrast	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.

Trial Locations

Locations (2)

UPMC Shadyside; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States