T-wave Alternans and Intrathoracic Impedance Measurements

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Congestive Heart Failure Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Congestive heart failure

Intervention Type OTHER

Spontaneous occurrence of fluid overload.

Interventions

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Congestive heart failure

Spontaneous occurrence of fluid overload.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Class III or IV heart failure patients with a chronically implanted Medtronic biventricular defibrillator system capable of monitoring intrathoracic fluid volume.