CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 156 enrolled
Drug / intervention
Fluid Status Monitoring (OptiVol™)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00289276
NCT00289276N/ACompleted
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FAST (Fluid Accumulation Status Trial)

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Feb 9, 2006·Updated Oct 13, 2010

In Brief

A clinical study evaluating Fluid Status Monitoring (OptiVol™) for Congestive Heart Failure and 4 related conditions. Completed, enrolled 156 participants across 16 sites in 3 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure, Cardiomyopathy, Dyspnea, Pulmonary Edema, Heart Diseases
CountriesCanada, China, United States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 9, 2006
Enrollment StartNov 1, 2003
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.4 years ago

Interventions

Fluid Status Monitoring (OptiVol™)device

Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial