FAST (Fluid Accumulation Status Trial)

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00289276
First received: February 7, 2006
Last updated: October 5, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Cardiomyopathy
Dyspnea
Pulmonary Edema
Heart Diseases
Device: Fluid Status Monitoring (OptiVol™)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: FAST (Fluid Accumulation Status Trial)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Number of Subjects With at Least 30 Days of Daily Impedance Measurements [ Time Frame: Up to 36 months. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.

  • 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 ] [ Designated as safety issue: No ]
    Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.

  • Number of Adverse Events [ Time Frame: From enrollment to study exit (up to 36 months). ] [ Designated as safety issue: No ]
    All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu


Enrollment: 156
Study Start Date: November 2003
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Fluid Status Monitoring (OptiVol™)
    Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289276

Locations
United States, Alaska
Alaska Cardiovascular Research Foundation
Anchorage, Alaska, United States, 99508
United States, Florida
Palm Beach Heart Institute
Atlantis, Florida, United States, 33462
United States, Indiana
Fort Wayne Cardiology
Ft. Wayne, Indiana, United States, 46805
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803
United States, Michigan
Michigan Cardiovascular Institute
Saginaw, Michigan, United States, 48601
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation Department of Hear Failure/Transplantation
Cleveland, Ohio, United States, 44195
The Ohio State University Hospital
Columbus, Ohio, United States, 43210
United States, Pennsylvania
The Pavillion at Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
United States, Texas
Texas Cardiac Arrhythmia Research
Austin, Texas, United States, 78758
United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84157
Canada, Alberta
University of Calgary/Foothills Hospital
Calgary, Alberta, Canada, T2N 4N1
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7V 2V7
China, Hong Kong
Queen Mary Hospital
Pok Fu Lam, Hong Kong, China
Prince of Wales Hospital/The Chinese University of Hong Kong
Shatin, Hong Kong, China
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: CRDM Clinical, Medtronic CRDM
ClinicalTrials.gov Identifier: NCT00289276     History of Changes
Other Study ID Numbers: 228
Study First Received: February 7, 2006
Results First Received: April 1, 2009
Last Updated: October 5, 2010
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
Canada: Canadian Institutes of Health Research

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Cardiomyopathy
Ventricular Ejection Fraction
Congestive Heart Failure
Impedance

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiomyopathies
Pulmonary Edema
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014