FAST (Fluid Accumulation Status Trial)
1 other identifier
interventional
156
3 countries
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedResults Posted
Study results publicly available
September 28, 2010
CompletedOctober 13, 2010
October 1, 2010
4.4 years
February 7, 2006
April 1, 2009
October 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF
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
1 day pre and 1 day post-outpatient visit
Number of Adverse Events
From enrollment to study exit (up to 36 months).
Interventions
Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Alaska Cardiovascular Research Foundation
Anchorage, Alaska, 99508, United States
Palm Beach Heart Institute
Atlantis, Florida, 33462, United States
Fort Wayne Cardiology
Fort Wayne, Indiana, 46805, United States
Genesis Medical Center
Davenport, Iowa, 52803, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, 48601, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation Department of Hear Failure/Transplantation
Cleveland, Ohio, 44195, United States
The Ohio State University Hospital
Columbus, Ohio, 43210, United States
The Pavillion at Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, 78758, United States
Intermountain Medical Center
Salt Lake City, Utah, 84157, United States
University of Calgary/Foothills Hospital
Calgary, Alberta, T2N 4N1, Canada
Kingston General Hospital
Kingston, Ontario, K7V 2V7, Canada
Queen Mary Hospital
Pok Fu Lam, Hong Kong, China
Prince of Wales Hospital/The Chinese University of Hong Kong
Shatin, Hong Kong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was a characterization study with no descriptive statistical analysis. The results reported were counts of subjects with impedance data available as applicable for each objective.
Results Point of Contact
- Title
- CRDM Core Clinical
- Organization
- Medtronic CRDM Clinical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 7, 2006
First Posted
February 9, 2006
Study Start
November 1, 2003
Primary Completion
April 1, 2008
Last Updated
October 13, 2010
Results First Posted
September 28, 2010
Record last verified: 2010-10