277
Participants
Start Date
March 31, 2003
Primary Completion Date
June 30, 2005
Study Completion Date
April 30, 2013
Chronicle Implantable Hemodynamic Monitor
Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead. The implantable hemodynamic monitoring device captures intracardiac hemodynamic information about the patient including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.
Standard of Care
Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead, but physician and patient access to the intracardiac information provided by the device is restricted until the end of the randomized period of the study, at 6 months. Patients and patients heart failure are managed conventionally per standard of care.
University of Alabama at Birmingham, Birmingham
Loma Linda University Medical Center, Loma Linda
UCLA Medical Center, Los Angeles
University of Southern California, Los Angeles
University of Florida - Shands, Gainesville
Crawford LongHospital, Atlanta
Prairie Heart Institute, Springfield
Parkview Memorial Hospital, Fort Wayne
New England Medical Center, Boston
St. Paul Heart, Saint Paul
Mid America Heart Institute, Kansas City
Robert Wood Johnson Medical Center, New Brunswick
Newark Beth Israel, Newark
New York Presbyterian - Columbia, New York
Duke University, Chapel Hill
University of Cincinnati, Cincinnati
The Ohio State University, Columbus
Oklahoma Cardiovascular Associates, Oklahoma City
University of Oklahoma, Oklahoma City
Hospital of the University of Pennsylvania, Philadelphia
Temple University Hospital, Philadelphia
University of Pittsburgh, Pittsburgh
Medical University of South Carolina, Charleston
Baptist Memorial Hospital, Germantown
St. Thomas Hospital, Nashville
St. Luke's Episcopal Hospital/Texas Heart, Houston
LDS Hospital, Salt Lake City
University of Washington Medical Center, Seattle
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY