224
Participants
Start Date
January 31, 2012
Primary Completion Date
July 31, 2014
Study Completion Date
July 31, 2014
Isolated veno-venous ultrafiltration (AQ)
Aquapheresis treatment (isolated veno-venous ultrafiltration) using the Aquadex FlexFlow System during index hospitalization until the patient's signs and symptoms of fluid overload have improved to the satisfaction of the treating physician. Ultrafiltration rates, duration and frequency of treatment are dependent on the amount of patient fluid excess and on the rate of fluid movement from the interstitial spaces into the vascular compartment during Aquapheresis (Plasma Refill Rate, or PRR)
IV Loop Diuretics (LD)
"IV Loop Diuretics treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload. This includes furosemide or other IV loop diuretics administered at equivalent doses to furosemide. Patients will receive either a twice daily IV bolus or continuous IV LD infusions according to the high dose protocol of theDiuretic strategies in patients wth acute decompensated heart failure (DOSE) trial."
St. Luke's Hospital and Health Network, Bethlehem
Abington Memorial Hospital, Abington
Drexel University College of Medicine, Philadelphia
University of Pennsylvania, Philadelphia
Albert Einstein Medical Center, Philadelphia
Washington Hospital Center, Washington D.C.
Virginia Commonwealth University Medical Center, Richmond
Asheville Cardiology Associates, Asheville
Emory University, Atlanta
Morton Plant Medical Center, Clearwater
Heart Center Research, Huntsville
Saint Thomas Hospital, Nashville
The Ohio State University, Columbus
MetroHealth Systems, Cleveland
Cleveland Clinic, Cleveland
University of Cincinnati, Cincinnati
Good Samaritan Hospital - Dayton, Dayton
Elkhart General HealthCare, Elkhart
Northern Indiana Research Alliance, Fort Wayne
Iowa Health - Des Moines, Des Moines
Aurora St. Luke's Medical Center, Milwaukee
Hennepin County Medical Center, Minneapolis
Minneapolis VA Medical Center, Minneapolis
University of Minnesota, Minneapolis
Advocate Health & Hospitals Corporation, Oakbrook Terrace
Northwestern University, Evanston
Edward Hospital Center for Advanced Heart Failure, Naperville
Saint Luke's Hospital and Saint Luke's Cardiovascular Consultants, Kansas City
Oklahoma Heart Institute and Hillcrest Medical Center, Tulsa
Brooke Army Medical Center, San Antonio
Mayo Clinic - Scottsdale, Scottsdale
Scottsdale Healthcare Research Institute, Scottsdale
New Mexico Heart Institute/Heart Hospital, Albuquerque
UCLA, Los Angeles
University of California, San Diego (UCSD), San Diego
San Diego Cardiac Center, San Diego
MultiCare Health System/Tacoma General Hospital, Tacoma
AtlantiCare Health Network, Egg Harbor
Lead Sponsor
Nuwellis, Inc.
INDUSTRY