T-wave Alternans and Intrathoracic Impedance Measurements
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|ClinicalTrials.gov Identifier: NCT00669682|
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : March 28, 2013
Last Update Posted : April 19, 2013
T-wave alternans is a test that is currently being used to risk stratify patients with structural heart disease for sudden cardiac death. The mechanism of T-wave alternans is unclear, but may share a common abnormality with conditions of cardiac fluid overload such as heart failure, which is altered intracellular calcium handling. Current Medtronic implantable defibrillators have the capability of monitoring cardiac fluid status via transthoracic impedance measurements.
The purpose of this study is to determine if a correlation exists between T-wave alternans status and cardiac volume status, as determined by transthoracic impedance measurements. Secondarily, the study seeks to examine the relationship between arrhythmia frequency and T-wave alternans or cardiac volume status.
|Condition or disease||Intervention/treatment|
|Congestive Heart Failure Arrhythmias||Other: Congestive heart failure|
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||T-wave Alternans and Intrathoracic Impedance Measurements|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
Other: Congestive heart failure
Spontaneous occurrence of fluid overload.
- Number of Positive Twave Studies and Concurrent Positive Optivol Measurement [ Time Frame: upto 3 years ]We wanted to examine whether positive Optivol status corresponded to a higher likelihood of a positive T wave study. The T wave alternans result is determined by a proprietary device that measures T wave and reports the result as negative, positive, or indeterminate. The Optivol measurement is obtained through transthoracic impedance values in the implanted device. We investigated the correlation between Optivol status and T wave alternans status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669682
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Jose M Dizon, MD||Columbia University|