FAST (Fluid Accumulation Status Trial)
- Conditions
- Congestive Heart FailureCardiomyopathyDyspneaPulmonary EdemaHeart Diseases
- Registration Number
- NCT00289276
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Subjects With at Least 30 Days of Daily Impedance Measurements 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 Outcome Measures
Name Time Method Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF 3 days pre-admission and 3 days post-discharge 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 1 day pre and 1 day post-outpatient visit Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.
Number of Adverse Events 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
Trial Locations
- Locations (16)
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Palm Beach Heart Institute
🇺🇸Atlantis, Florida, United States
The Ohio State University Hospital
🇺🇸Columbus, Ohio, United States
Fort Wayne Cardiology
🇺🇸Ft. Wayne, Indiana, United States
The Pavillion at Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Michigan Cardiovascular Institute
🇺🇸Saginaw, Michigan, United States
Cleveland Clinic Foundation Department of Hear Failure/Transplantation
🇺🇸Cleveland, Ohio, United States
Queen Mary Hospital
🇨🇳Pok Fu Lam, Hong Kong, China
Prince of Wales Hospital/The Chinese University of Hong Kong
🇨🇳Shatin, Hong Kong, China
Alaska Cardiovascular Research Foundation
🇺🇸Anchorage, Alaska, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
University of Calgary/Foothills Hospital
🇨🇦Calgary, Alberta, Canada
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States