N/A
Completed N=9
T-wave Alternans and Intrathoracic Impedance Measurements
Source: ClinicalTrials.gov NCT00669682 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Number of Positive Twave Studies and Concurrent Positive Optivol Measurement — 1; 1; 2; 5 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Positive Twave Studies and Concurrent Positive Optivol Measurement |
1; 1; 2; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00669682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.