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Trial record 2 of 5 for:    Monitoring Resynchronization Devices and Cardiac Patients

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579641
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Heart Failure Defibrillators, Implantable Monitoring, Physiologic Cardiac Resynchronization Therapy Cardiovascular Disease Heart Disease Device: HeartLogic Sensors

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.).

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Study Type : Observational
Estimated Enrollment : 3750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579641


Contacts
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Contact: Karen L Reidt, MBA 651-202-8033 karen.reidt@bsci.com
Contact: Maria Paz Lopez-Chicharro 32-024167201 Maria.Lopez-Chicharro@bsci.com

Locations
Show Show 88 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Stephen Gaertner Boston Scientific Corporation
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Study Protocol  [PDF] April 10, 2018

Publications:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03579641    
Other Study ID Numbers: PREEMPT-HF
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Boston Scientific Corporation:
Heart Failure
Cardiac Resynchronization Therapy Defibrillator
Heart Failure Sensor Data
30-day Heart Failure Readmission
Latitude Remote Patient Monitor
Implantable Cardioverter Defibrillator
Ventricular Tachycardia/Ventricular Fibrillation Therapy
Non-Heart Failure Hospitalization
HeartLogic Feature
Data Linkage
Sleep Incline Sensor
Respiratory Sensor
Decongestive Intravenous therapy
Decompensation
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases