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Completed

NCT Number: NCT00289276

FAST (Fluid Accumulation Status Trial)

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.

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Key information

Conditions

Congestive Heart Failure Cardiomyopathies Cardiomyopathy Cardiovascular Diseases Dyspnea Heart Diseases Heart Failure Lung Diseases Pathological Conditions, Signs and Symptoms Pulmonary Edema Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary/Foothills Hospital, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluid Status Monitoring (OptiVol™)

Device

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

Primary outcomes

  1. Number of Subjects With at Least 30 Days of Daily Impedance Measurements

    Time frame: Up to 36 months.

    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.

Secondary outcomes

  1. Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF

    Time frame: 3 days pre-admission and 3 days post-discharge

    Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.

  2. Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF

    Time frame: 1 day pre and 1 day post-outpatient visit

    Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.

  3. Number of Adverse Events

    Time frame: From enrollment to study exit (up to 36 months).

    All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2003
Primary completion
2008
First posted
Feb 9, 2006
Registry last updated
Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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