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| Sponsored by: |
University of Pittsburgh |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00890461 |
Purpose
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.
| Condition |
|---|
|
Implantation of an Internal Defibrillator |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2007 |
| Groups/Cohorts |
|---|
|
Defibrillator
The subject population will be obtained by approaching the Principal and Co- Investigators' patients who have been referred for ICD implantation. This population ranges in age from 18 years on, and includes both males and females. A maximum of 30 subjects will be enrolled in this study.
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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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Subjects will be identified by their cardiologist who is also an investigator on this study at the time they are evaluated for an ICD implantation.
Once it has been determined during the course of the patient's regular clinical care that he or she requires an ICD, they will be approached for enrollment into the study by the physician investigator and the clinical research coordinator.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Samir F Saba, MD | 412-647-6272 | sabas@upmc.edu |
| Contact: Susan A Mularski, BS | 412-648-6024 | mularskisa@upmc.edu |
| United States, Pennsylvania | |
| UPMC Presbyterian | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Susan A Mularski, BS 412-648-6024 mularskisa@upmc.edu | |
| Principal Investigator: Samir F. Saba, MD | |
| Sub-Investigator: Stuart Mendenhall, MD | |
| UPMC Shadyside | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Susan A Mularski, BS 412-648-6024 mularskisa@upmc.edu | |
| Principal Investigator: Samir F Saba, MD | |
| Sub-Investigator: Stuart G Mendenhall, MD | |
| Principal Investigator: | Samir F Saba, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Samir Saba, M.D. ) |
| Study ID Numbers: | PRO07080211 |
| Study First Received: | April 28, 2009 |
| Last Updated: | April 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00890461 History of Changes |
| Health Authority: | United States: Institutional Review Board |
