FAST (Fluid Accumulation Status Trial)

Completed · Not applicable

Conditions studied: Congestive Heart Failure, Cardiomyopathy, Dyspnea, Pulmonary Edema, Heart Diseases

In brief

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.

Key facts

Study ID

NCT00289276

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

156

Starts

2003-11-01

Last updated by the study team

2010-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Alaska Cardiovascular Research Foundation — Anchorage, Alaska, United States
• Palm Beach Heart Institute — Atlantis, Florida, United States
• Fort Wayne Cardiology — Fort Wayne, Indiana, United States
• Genesis Medical Center — Davenport, Iowa, United States
• Michigan Cardiovascular Institute — Saginaw, Michigan, United States
• North Shore University Hospital — Manhasset, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation Department of Hear Failure/Transplantation — Cleveland, Ohio, United States
• The Ohio State University Hospital — Columbus, Ohio, United States
• The Pavillion at Doylestown Hospital — Doylestown, Pennsylvania, United States
• Texas Cardiac Arrhythmia Research — Austin, Texas, United States
• Intermountain Medical Center — Salt Lake City, Utah, United States
• University of Calgary/Foothills Hospital — Calgary, Alberta, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• Queen Mary Hospital — Pok Fu Lam, Hong Kong, China
• Prince of Wales Hospital/The Chinese University of Hong Kong — Shatin, Hong Kong, China

Full record on ClinicalTrials.gov

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