Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-06-02 @ 7:49 AM
Study NCT ID:
NCT00890461
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2009-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1. Ischemia detection
2. Myocardial Infarction detection
3. Electrolyte abnormalities detection
4. Assessment of effect of medications
5. Improved rhythm discrimination
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: