Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
NCT ID: NCT03579641
Last Updated: 2022-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2184 participants
OBSERVATIONAL
2018-06-01
2021-10-29
Brief Summary
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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.
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Detailed Description
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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.).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Implantable Cardiac device with HeartLogic feature
Patients with Heart Failure, implanted with Boston Scientific Implantable Cardioverter Defibrillator or Defibrillator with Cardiac Resynchronization device with HeartLogic feature
HeartLogic Sensors
HeartLogic Sensors
Interventions
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HeartLogic Sensors
HeartLogic Sensors
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Gaertner
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States
Baptist Health Medical Center (Little Rock)
Little Rock, Arkansas, United States
Providence St. Joseph Medical Center
Burbank, California, United States
Mission Hospital
Mission Viejo, California, United States
Stanford University Medical Center
Stanford, 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
Watson Clinic Center for Research, Inc.
Lakeland, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Florida Hospital
Winter Park, Florida, United States
CorVita Science Foundation (NFP)
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, 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
University of Kansas Hospital
Kansas City, Kansas, United States
Eastern Maine Medical Center
Bangor, Maine, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Mass Heart and Rhythm
Leominster, Massachusetts, United States
Advanced Cardiovascular Clinic
Flint, Michigan, 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
St 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
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Southern Oregon Cardiology, LLC
Medford, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
St. Francis Health System - St. Francis Hospital
Greenville, South Carolina, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Seton Medical Center
Austin, Texas, United States
The University of Texas, Southwestern Medical Center
Dallas, Texas, United States
Orion Medical
Pasadena, Texas, United States
Christus Trinity Mother Frances Health System
Tyler, Texas, United States
Riverside Regional Medical Center
Newport News, Virginia, 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
OLVZ Aalst
Aalst, , Belgium
CHUM
Montreal, , Canada
IUCPQ
Ste-Foy, , Canada
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
CHU de St. Etienne
Saint-Priest-en-Jarez, , France
Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie
Bochum, , Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, , Germany
Grantham Hospital
Aberdeen, , Hong Kong
Prince of Wales Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
University Hospital Waterford
Waterford, , Ireland
Az. Osp. G. Ciaccio Pontepiccolo
Catanzaro, , Italy
Az. Osp. Monaldi
Naples, , Italy
Ospedale Sacro Cuore Don Calabria
Negrar, , Italy
Azienda Osp Univ Integrata di Verona
Verona, , Italy
AMC
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum
Utrecht, , 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
Golden Jubilee National Hospital
Clydebank, , United Kingdom
Ninewells Hospital and Medical School
Dundee, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
South Manchester University Hospital Trust
Manchester, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041.
Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.
Whellan DJ, Lindenfeld J. Easy to Predict, Difficult to Prevent. JACC Heart Fail. 2017 Mar;5(3):226-228. doi: 10.1016/j.jchf.2017.01.006. No abstract available.
Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.
Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA. 2017 Jul 18;318(3):270-278. doi: 10.1001/jama.2017.8444.
Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.
Sauer AJ, Stolen CM, Shute JB, Kwan B, Wariar R, Ruble SB, Gardner RS, Boehmer JP. Results of the Precision Event Monitoring for Patients With Heart Failure Using HeartLogic Study (PREEMPT-HF). JACC Heart Fail. 2025 Jun;13(6):973-983. doi: 10.1016/j.jchf.2025.01.028. Epub 2025 Apr 23.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PREEMPT-HF
Identifier Type: -
Identifier Source: org_study_id
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