Last updated on May 2020

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic


Brief description of study

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 Study 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.).

Clinical Study Identifier: NCT03579641

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Cardiology Physicians, PA

Newark, DE United States
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St. John's

Springfield, IL United States
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Mass Heart and Rhythm

Leominster, MA United States
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Hattiesburg Clinic, P.A.

Hattiesburg, MS United States
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Abington Memorial Hospital

Abington, PA United States
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OLVZ Aalst

Aalst, Belgium
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CHUM

Montréal, Canada
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IUCPQ

Ste-Foy, Canada
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CHU de St. Etienne

Saint-Priest-en-Jarez, France
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Queen Mary Hospital

Hong Kong, Hong Kong
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AMC

Amsterdam, Netherlands
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Belfast City Hospital

Belfast, United Kingdom
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Northern General Hospital

Sheffield, United Kingdom
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New Cross Hospital

Wolverhampton, United Kingdom
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Mission Hospital

Mission Viejo, CA United States
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Harbor UCLA Medical Center

Torrance, CA United States
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Baptist Medical Center

Jacksonville, FL United States
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Sarasota Memorial Hospital

Sarasota, FL United States
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Tallahassee Memorial Hospital

Tallahassee, FL United States
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Florida Hospital

Winter Park, FL United States
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Evanston Hospital

Evanston, IL United States
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St. John's Hospital

Springfield, IL United States
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Carle Foundation Hospital

Urbana, IL United States
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University of Kansas Hospital

Kansas City, KS United States
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Boston Medical Center

Boston, MA United States
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Bronson Methodist Hospital

Kalamazoo, MI United States
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William Beaumont Hospital

Royal Oak, MI United States
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Regions Hospital

Saint Paul, MN United States
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Barnes Jewish Hospital

Saint Louis, MO United States
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Albany Medical Center

Albany, NY United States
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Aultman Hospital

Canton, OH United States
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Lehigh Valley Hospital

Allentown, PA United States
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Erlanger Medical Center

Chattanooga, TN United States
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Seton Medical Center

Austin, TX United States
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Orion Medical

Pasadena, TX United States
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Riverside Regional Medical Center

Newport News, VA United States
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St. Mary's Medical Center

Huntington, WV United States
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Grantham Hospital

Aberdeen, Hong Kong
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Recruitment Status: Open


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