Detect Fluid Early From Intra-thoracic Impedance Monitoring
- Conditions
- Heart Failure
- Interventions
- Device: Impedance Monitoring Feature
- Registration Number
- NCT00916929
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
- Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months
- History of kidney disease requiring hemodialysis
- Refractory end stage heart failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Implantable Cardioverter Defibrillator (ICD) Impedance Monitoring Feature Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD). Cardiac Resynchronization Therapy (CRT-D) Impedance Monitoring Feature Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.
- Primary Outcome Measures
Name Time Method False Positive Rate 6-months False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.
- Secondary Outcome Measures
Name Time Method Sensitivity 6-months Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).
Trial Locations
- Locations (34)
York Hospital
🇺🇸York, Pennsylvania, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Shands Jacksonville
🇺🇸Jacksonville, Florida, United States
Colorado Cardiac Alliance, LLC
🇺🇸Colorado Springs, Colorado, United States
New York Presbyterian Hospital / Cornell University
🇺🇸New York, New York, United States
Little Rock Cardiology Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Cardiac Rhythm Specialists, Inc
🇺🇸Northridge, California, United States
Mercy Hospital Fairfield
🇺🇸Fairfield, Ohio, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Thoracic Cardiovascular HC Found. (Sparrow Research)
🇺🇸Lansing, Michigan, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Glendale Memorial Hospital and MC
🇺🇸Glendale, California, United States
Watson Clinic Center
🇺🇸Lakeland, Florida, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Saint Vincent Consultants in Cardiovascular Diseases
🇺🇸Erie, Pennsylvania, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Cardiology Consultants of East Michigan
🇺🇸Flint, Michigan, United States
Associated Cardiovascular Consultants
🇺🇸Cherry Hill, New Jersey, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
The Hope Heart Institute
🇺🇸Bellevue, Washington, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
St Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Arkansas Cardiology, PA
🇺🇸Little Rock, Arkansas, United States
Hospital of the University of PA
🇺🇸Philadelphia, Pennsylvania, United States
Mid Carolina Cardiology
🇺🇸Charlotte, North Carolina, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Arizona Arrhythmia Research Center
🇺🇸Phoenix, Arizona, United States
Orlando Heart Center
🇺🇸Orlando, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States