FAST (Fluid Accumulation Status Trial)

Study Overview
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Brief Summary
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Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using very low electrical pulses that travel across the inside of the chest cavity, thoracic fluid status monitoring (OptiVol™) can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the chest. The purpose of this study is to collect information related to fluid build up in the chest of subjects with heart failure.

Official Title
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FAST (Fluid Accumulation Status Trial)

Conditions
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Congestive Heart Failure, Cardiomyopathy, Dyspnea, Pulmonary Edema, Heart Diseases

Intervention / Treatment
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* Device: Fluid Status Monitoring (OptiVol™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with one of the following implantable cardioverter defibrillators (ICDs): InSync Marquis™, InSync II Marquis™, Marquis® DR, or InSync III Marquis™. Subjects with an ICD placed in the upper part of the left or right side of their chest. Subjects with a lead (flexible wire that sends electrical signals from the ICD directly to the heart tissue) that is inserted through a vein and placed in the right ventricle (RV) of the heart (a transvenous RV lead). Subjects who underwent the ICD implant procedure, or any readjusting of the ICD, 30 days or more prior to enrolling in the study. Exclusion Criteria: Subjects who are already enrolled in another clinical study. Subjects who have received a heart transplant. Subjects who are unable or unwilling to follow the study schedule of visits.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fluid Status Monitoring (OptiVol™)|Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least 30 Days of Daily Impedance Measurements | Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period. | Up to 36 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF | Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization. | 3 days pre-admission and 3 days post-discharge | 
| Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF | Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit. | 1 day pre and 1 day post-outpatient visit | 
| Number of Adverse Events | All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu | From enrollment to study exit (up to 36 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiomyopathy, Ventricular Ejection Fraction, Congestive Heart Failure, Impedance