Heart Failure Clinical Trial
Multiple Cardiac Sensors for the Management of Heart Failure
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.
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.
Subject is age 18 or above, or of legal age to give informed consent
Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
Remotely monitored by LATITUDE 5.0 (or future versions)
Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
Meet at least one of the three following conditions:
At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment
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 time of 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 ventricular assist 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 from Boston Scientific, excluding registries)
Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics)
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 at anytime within the past 6 months.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 30 Locations for this study
Huntsville Alabama, 35801, United States
Jonesboro Arkansas, 72401, United States
Los Angeles California, 90033, United States
Oakland California, 94609, United States
San Diego California, 92123, United States
San Francisco California, 94143, United States
Aurora Colorado, 80045, United States
Atlanta Georgia, 30322, United States
Fort Wayne Indiana, 46805, United States
Indianapolis Indiana, 46250, United States
Shreveport Louisiana, 71105, United States
Cold Spring Minnesota, 56320, United States
Saint Paul Minnesota, 55102, United States
Manchester New Hampshire, 03102, United States
Bronx New York, 10467, United States
Rochester New York, 14642, United States
Durham North Carolina, 27705, United States
Raleigh North Carolina, 27607, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45220, United States
Springfield Oregon, 97477, United States
Hershey Pennsylvania, 17033, United States
Yardley Pennsylvania, 19067, United States
Charleston South Carolina, 29425, United States
Germantown Tennessee, 38138, United States
Beaumont Texas, 77702, United States
Norfolk Virginia, 23507, United States
Nantes , 44277, France
Rennes , 35033, France
Würzburg , 97080, Germany
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.