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

ICD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890461
• Other study ID #: PRO07080211
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: May 1, 2017
• Start date: November 2007
• Est. completion date: February 8, 2017

Study information

• Verified date: May 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 8, 2017
• Est. primary completion date: February 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ICD

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	UPMC Shadyside	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States,