Precision Event Monitoring for Patients With Heart Failure Using HeartLogic (PREEMPT-HF)

October 24, 2022 updated by: Boston Scientific Corporation

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.).

Study Type

Observational

Enrollment (Actual)

2184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Chermside, Australia
        • Prince Charles Hospital
  • Belgium
      • Aalst, Belgium
        • OLVZ Aalst
  • Canada
      • Montréal, Canada
        • CHUM
      • Ste-Foy, Canada
        • IUCPQ
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
  • France
      • Caen, France
        • CHU de Caen
      • Nantes, France
        • CHU de Nantes - Hopital Laennec
      • Paris, France
        • APHP - Hospital de la Pitie-Salpetriere
      • Saint-Priest-en-Jarez, France
        • CHU de St. Etienne
  • Germany
      • Bochum, Germany
        • Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie
      • Lübeck, Germany
        • Universitaetsklinikum Schleswig-Holstein
  • Hong Kong
      • Aberdeen, Hong Kong
        • Grantham Hospital
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • Ireland
      • Waterford, Ireland
        • University Hospital Waterford
  • Italy
      • Catanzaro, Italy
        • Az. Osp. G. Ciaccio Pontepiccolo
      • Naples, Italy
        • Az. Osp. Monaldi
      • Negrar, Italy
        • Ospedale Sacro Cuore Don Calabria
      • Verona, Italy
        • Azienda Osp Univ Integrata di Verona
  • Netherlands
      • Amsterdam, Netherlands
        • AMC
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Utrecht, Netherlands
        • Universitair Medisch Centrum
  • Spain
      • Barcelona, Spain
        • Hospital Clinic de Barcelona
      • Las Palmas, Spain
        • Hospital De Gran Canaria Dr. Negrin
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
  • United Kingdom
      • Belfast, United Kingdom
        • Belfast City Hospital
      • Clydebank, United Kingdom
        • Golden Jubilee National Hospital
      • Dundee, United Kingdom
        • Ninewells Hospital and Medical School
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh
      • Manchester, United Kingdom
        • South Manchester University Hospital Trust
      • Sheffield, United Kingdom
        • Northern General Hospital
      • Wolverhampton, United Kingdom
        • New Cross Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35211
        • Baptist Medical Center Princeton
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Cardiology Associates of Northeast Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Medical Center (Little Rock)
    • California
      • Burbank, California, United States, 91505
        • Providence St. Joseph Medical Center
      • Mission Viejo, California, United States, 92691
        • Mission Hospital
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Torrance, California, United States, 90502
        • Harbor Ucla Medical Center
      • Torrance, California, United States, 90503
        • Torrance Memorial Medical Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Cardiology Physicians, PA
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center for Research, Inc.
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
      • Winter Park, Florida, United States, 32792
        • Florida Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60605
        • CorVita Science Foundation (NFP)
      • Evanston, Illinois, United States, 60201
        • Evanston Hospital
      • Springfield, Illinois, United States, 62701
        • St. John's Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical System
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Leominster, Massachusetts, United States, 01453
        • Mass Heart and Rhythm
    • Michigan
      • Flint, Michigan, United States, 48532
        • Advanced Cardiovascular Clinic
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital-Duluth
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic, P.A.
      • Hattiesburg, Mississippi, United States, 39401
        • Heart and Vascular Hattiesburg Clinic
    • Missouri
      • Pontiac, Missouri, United States, 48341
        • St. Joseph Mercy Hospital Oakland
      • Saint Louis, Missouri, United States, 63110-1093
        • Barnes Jewish Hospital
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Albany, New York, United States, 12211
        • Capital Cardiology Associates
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital of the University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospital
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
    • Oregon
      • Medford, Oregon, United States, 97504
        • Southern Oregon Cardiology, LLC
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18103
        • LeHigh Valley Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • St. Francis Health System - St. Francis Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Nashville, Tennessee, United States, 37232-8802
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Medical Center
      • Dallas, Texas, United States, 75390-8837
        • The University of Texas, Southwestern Medical Center
      • Pasadena, Texas, United States, 77505
        • Orion Medical
      • Tyler, Texas, United States, 75701
        • Christus Trinity Mother Frances Health System
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Riverside Regional Medical Center
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Center Everett
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • St. Mary's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Heart Failure implanted with Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator using HeartLogic

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: HeartLogic Sensors
HeartLogic Sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of HeartLogic sensors with 30-day HF re-admission
Time Frame: 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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Stephen Gaertner, Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

October 29, 2021

Study Completion (Actual)

October 29, 2021

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREEMPT-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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