Multiple Cardiac Sensors for the Management of Heart Failure

Last updated: February 29, 2024
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Chest Pain

Hyponatremia

Treatment

HeartLogic ON

HeartLogic OFF

Clinical Study ID

NCT03237858
92125179
  • Ages > 18
  • All Genders

Study Summary

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is age 18 or above, or of legal age to give informed consent
  2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) orimplantable cardioverter-defibrillator (ICD) device that has HeartLogic
  3. Current symptomatic heart failure or New York Heart Association Class II or III at thetime of enrollment
  4. Remotely monitored by LATITUDE 5.0 (or future versions)
  5. Willing and capable of participating in all study visits and complying withmedication/treatment requirements associated with this clinical study at an approvedclinical study center.
  6. Meet at least one of the three following conditions:
  • At least one documented hospitalization with a primary diagnosis of worsening forheart failure during the 12 months prior to enrollment; or
  • Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HFduring 90 days prior to enrollment; or
  • N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL orbrain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 daysprior to enrollment

Exclusion

Exclusion Criteria:

  1. The subject is unable to sign or refuses to sign the patient informed consent
  2. Symptomatic heart failure at rest or New York Heart Association Class IV at the timeof enrollment
  3. The subject is implanted with unipolar right atrial or right ventricular leads
  4. Subject has received or is scheduled to receive a heart transplant or ventricularassist device within the next 6 months
  5. Subject is pregnant or planning to become pregnant during the study
  6. Subject is enrolled in any other concurrent study (without prior written approval fromBoston Scientific, excluding registries)
  7. Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy orare on chronic renal dialysis
  8. Regularly scheduled intravenous heart failure therapy (for example inotropes ordiuretics)
  9. A life expectancy of less than 12 months per clinician discretion
  10. APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF
  11. APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON atanytime within the past 6 months.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: HeartLogic ON
Phase:
Study Start date:
August 30, 2017
Estimated Completion Date:
July 21, 2020

Study Description

Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints.

Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts.

Connect with a study center

  • L'Hôpital privé du Confluent

    Nantes, 44277
    France

    Site Not Available

  • CHU Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Universitätsklinikum Würzburg AöR

    Würzburg, 97080
    Germany

    Site Not Available

  • Heart Center Research, LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Cardiology Associates of Northeast Arkansas

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • University of Southern California Hospital

    Los Angeles, California 90033
    United States

    Site Not Available

  • Cardiovascular Consultants

    Oakland, California 94609
    United States

    Site Not Available

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Parkview Hospital, Inc.

    Fort Wayne, Indiana 46805
    United States

    Site Not Available

  • Community Health Network

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Advanced Cardiovascular Specialists

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Centra Care Heart and Vascular Center

    Cold Spring, Minnesota 56320
    United States

    Site Not Available

  • United Heart and Vascular

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Catholic Medical Center

    Manchester, New Hampshire 03102
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Strong Memorial Hospital of the University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Rex Hospital

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Bethesda North Hospital

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • Lindner Center for Research and Education at Christ Hosp

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • PeaceHealth Sacred Heart Medical Center

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania 19067
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Stern Cardiovascular

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Southeast Texas Clinical Research Center

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

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