Phase
Condition
Heart Failure
Chest Pain
Hyponatremia
Treatment
HeartLogic ON
HeartLogic OFF
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject is age 18 or above, or of legal age to give informed consent
- Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) orimplantable cardioverter-defibrillator (ICD) device that has HeartLogic
- Current symptomatic heart failure or New York Heart Association Class II or III at thetime of enrollment
- Remotely monitored by LATITUDE 5.0 (or future versions)
- Willing and capable of participating in all study visits and complying withmedication/treatment requirements associated with this clinical study at an approvedclinical study center.
- 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:
- The subject is unable to sign or refuses to sign the patient informed consent
- Symptomatic heart failure at rest or New York Heart Association Class IV at the timeof enrollment
- The subject is implanted with unipolar right atrial or right ventricular leads
- Subject has received or is scheduled to receive a heart transplant or ventricularassist device within the next 6 months
- Subject is pregnant or planning to become pregnant during the study
- Subject is enrolled in any other concurrent study (without prior written approval fromBoston Scientific, excluding registries)
- Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy orare on chronic renal dialysis
- Regularly scheduled intravenous heart failure therapy (for example inotropes ordiuretics)
- A life expectancy of less than 12 months per clinician discretion
- APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF
- APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON atanytime within the past 6 months.
Study Design
Study Description
Connect with a study center
L'Hôpital privé du Confluent
Nantes, 44277
FranceSite Not Available
CHU Pontchaillou
Rennes, 35033
FranceSite Not Available
Universitätsklinikum Würzburg AöR
Würzburg, 97080
GermanySite Not Available
Heart Center Research, LLC
Huntsville, Alabama 35801
United StatesSite Not Available
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas 72401
United StatesSite Not Available
University of Southern California Hospital
Los Angeles, California 90033
United StatesSite Not Available
Cardiovascular Consultants
Oakland, California 94609
United StatesSite Not Available
Sharp Memorial Hospital
San Diego, California 92123
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94143
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30322
United StatesSite Not Available
Parkview Hospital, Inc.
Fort Wayne, Indiana 46805
United StatesSite Not Available
Community Health Network
Indianapolis, Indiana 46250
United StatesSite Not Available
Advanced Cardiovascular Specialists
Shreveport, Louisiana 71105
United StatesSite Not Available
Centra Care Heart and Vascular Center
Cold Spring, Minnesota 56320
United StatesSite Not Available
United Heart and Vascular
Saint Paul, Minnesota 55102
United StatesSite Not Available
Catholic Medical Center
Manchester, New Hampshire 03102
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
Strong Memorial Hospital of the University of Rochester
Rochester, New York 14642
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
Rex Hospital
Raleigh, North Carolina 27607
United StatesSite Not Available
Bethesda North Hospital
Cincinnati, Ohio 45220
United StatesSite Not Available
Lindner Center for Research and Education at Christ Hosp
Cincinnati, Ohio 45219
United StatesSite Not Available
PeaceHealth Sacred Heart Medical Center
Springfield, Oregon 97477
United StatesSite Not Available
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania 19067
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Stern Cardiovascular
Germantown, Tennessee 38138
United StatesSite Not Available
Southeast Texas Clinical Research Center
Beaumont, Texas 77702
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesSite Not Available
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