Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
- Conditions
- Heart FailureHeart DiseaseCardiac Resynchronization TherapyCardiovascular DiseaseDefibrillators, ImplantableMonitoring, Physiologic
- Interventions
- Device: HeartLogic Sensors
- Registration Number
- NCT03579641
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study.
Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.
- Detailed Description
Subjects will be followed for approximately 12 months after the baseline visit to collect the required number of clinical events to support the study objectives. These events are called Reviewable Clinical Events, and include all-cause hospitalizations and Heart Failure outpatient visits.
Clinical event definitions are as follows:
* Hospitalization (all-cause): the subject is admitted to inpatient hospital care and discharged on a different calendar date.
* Heart Failure Hospitalization: the subject is admitted with signs/symptoms of congestive heart failure and receives unscheduled augmented Heart Failure therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy.
* Heart Failure Readmission (30-day): the subject is admitted for an unplanned hospitalization for any cause within 30 days post discharge from a Heart Failure hospitalization.
* Heart Failure Outpatient Visit: the subject has signs/symptoms of Congestive Heart Failure, and receives unscheduled intravenous decongestive therapy (e.g., Intravenous diuretics, Intravenous inotropes, Intravenous vasoactive drugs, ultrafiltration) in a setting that does not involve a hospitalization (e.g., emergency room, Heart Failure clinic, primary care clinic, etc.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2184
- Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws.
- Subject has a documented diagnosis of heart failure.
- Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON.
- Subject has an active bipolar right ventricle lead implant.
- Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled.
- Subject has received or is scheduled to receive a heart transplant or ventricular assist device (VAD).
- Subject is enrolled in any concurrent clinical study without prior Boston Scientific written approval (excluding registries).
- Subject has a life expectancy of less than 12 months.
- Subject has a history of non-compliance to medical care or known inability to comply with requirements of the clinical study protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Implantable Cardiac device with HeartLogic feature HeartLogic Sensors Patients with Heart Failure, implanted with Boston Scientific Implantable Cardioverter Defibrillator or Defibrillator with Cardiac Resynchronization device with HeartLogic feature
- Primary Outcome Measures
Name Time Method Association of HeartLogic sensors with 30-day HF re-admission Heartlogic sensor data will be evaluated for the association to HF re-admission during the 30 days after the index event (e.g. the first HF hospitalization that occurs during the trial). To compare a mean sensor value change (admission - discharge) between the no-readmission group and the 30-day readmission group.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (88)
Cardiology Associates of Northeast Arkansas
🇺🇸Jonesboro, Arkansas, United States
Baptist Health Medical Center (Little Rock)
🇺🇸Little Rock, Arkansas, United States
Mission Hospital
🇺🇸Mission Viejo, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Providence St. Joseph Medical Center
🇺🇸Burbank, California, United States
Harbor UCLA Medical Center
🇺🇸Torrance, California, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Cardiology Physicians, PA
🇺🇸Newark, Delaware, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Florida Hospital
🇺🇸Winter Park, Florida, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Advanced Cardiovascular Clinic
🇺🇸Flint, Michigan, United States
Mass Heart and Rhythm
🇺🇸Leominster, Massachusetts, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
St. Luke's Hospital-Duluth
🇺🇸Duluth, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Hattiesburg Clinic, P.A.
🇺🇸Hattiesburg, Mississippi, United States
Heart and Vascular Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
St. Joseph Mercy Hospital Oakland
🇺🇸Pontiac, Missouri, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Capital Cardiology Associates
🇺🇸Albany, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Strong Memorial Hospital of the University of Rochester
🇺🇸Rochester, New York, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Southern Oregon Cardiology, LLC
🇺🇸Medford, Oregon, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
St. Francis Health System - St. Francis Hospital
🇺🇸Greenville, South Carolina, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
The University of Texas, Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Riverside Regional Medical Center
🇺🇸Newport News, Virginia, United States
Orion Medical
🇺🇸Pasadena, Texas, United States
Christus Trinity Mother Frances Health System
🇺🇸Tyler, Texas, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Prince Charles Hospital
🇦🇺Chermside, Australia
IUCPQ
🇨🇦Ste-Foy, Canada
OLVZ Aalst
🇧🇪Aalst, Belgium
Aarhus University Hospital
🇩🇰Aarhus, Denmark
CHU de Caen
🇫🇷Caen, France
CHU de Nantes - Hôpital Laennec
🇫🇷Nantes, France
APHP - Hospital de la Pitie-Salpetriere
🇫🇷Paris, France
Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie
🇩🇪Bochum, Germany
CHU de St. Etienne
🇫🇷Saint-Priest-en-Jarez, France
Universitaetsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Grantham Hospital
ðŸ‡ðŸ‡°Aberdeen, Hong Kong
University Hospital Waterford
🇮🇪Waterford, Ireland
Az. Osp. G. Ciaccio Pontepiccolo
🇮🇹Catanzaro, Italy
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
Azienda Osp Univ Integrata di Verona
🇮🇹Verona, Italy
Az. Osp. Monaldi
🇮🇹Naples, Italy
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital de Gran Canaria Dr. Negrin
🇪🇸Las Palmas, Spain
Hospital Universitario Virgen De La Victoria
🇪🇸Málaga, Spain
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, United Kingdom
Golden Jubilee National Hospital
🇬🇧Clydebank, United Kingdom
South Manchester University Hospital Trust
🇬🇧Manchester, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
CorVita Science Foundation (NFP)
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Maryland Medical System
🇺🇸Baltimore, Maryland, United States
Universitair Medisch Centrum
🇳🇱Utrecht, Netherlands
CHUM
🇨🇦Montréal, Canada
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
AMC
🇳🇱Amsterdam, Netherlands
Baptist Medical Center Princeton
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
University of North Carolina Hospital
🇺🇸Chapel Hill, North Carolina, United States
Seton Medical Center
🇺🇸Austin, Texas, United States
Watson Clinic Center for Research, Inc.
🇺🇸Lakeland, Florida, United States
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong