T-wave Alternans and Intrathoracic Impedance Measurements
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Congestive Heart Failure Arrhythmias |
Other: Congestive heart failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | T-wave Alternans and Intrathoracic Impedance Measurements |
- Number of Positive Twave Studies and Concurrent Positive Optivol Measurement [ Time Frame: upto 3 years ] [ Designated as safety issue: No ]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.
| Enrollment: | 9 |
| Study Start Date: | August 2008 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group A
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Class III or IV heart failure patients
Inclusion Criteria:
- Class III or IV heart failure patients with a chronically implanted Medtronic biventricular defibrillator system capable of monitoring intrathoracic fluid volume.
Exclusion Criteria:
- no active ischemia or pulmonary edema, atrial fibrillation, complete heart block
Contacts and Locations| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Jose M Dizon, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | Jose M. Dizon, Assoc Professor of Clinical, Department of Cardiology, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00669682 History of Changes |
| Other Study ID Numbers: | AAAC5529 |
| Study First Received: | April 28, 2008 |
| Results First Received: | February 15, 2013 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Failure Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013