MANAGE-HFHeartLogic Feature in CRT-D or ICD Devices for Heart Failure Management
This study aims to evaluate and optimize the integration and alert management of the HeartLogic feature in CRT-D or ICD devices for heart failure management.
HeartLogic ON
+ HeartLogic OFF
Cardiovascular Diseases
+ Heart Diseases
+ Heart Failure
Diagnostic Study
Summary
Study start date: August 30, 2017
Actual date on which the first participant was enrolled.The MANAGE-HF trial is a study focused on improving the management of heart failure. It looks at how well a system called HeartLogic can help doctors monitor and care for patients with heart failure. This system is part of certain implanted heart devices, like CRT-D or ICD cardiac devices. It uses various heart and breathing indicators to signal when a patient's heart failure might be getting worse. The study is important because it could lead to better ways to manage heart failure, potentially improving patients' quality of life and reducing hospital visits. The study has two parts. The first part, Phase I, is about seeing how well HeartLogic can be used in a clinical setting, but it doesn't have specific endpoints or outcome measures. The second part, Phase II, compares two groups of patients. One group receives remote monitoring using HeartLogic alerts, while the other group gets remote monitoring but without these alerts. The goal is to see if using HeartLogic alerts leads to better heart failure care and outcomes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic 3. Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment 4. Remotely monitored by LATITUDE 5.0 (or future versions) 5. 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. 6. 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 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 time of 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 ventricular assist 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 from Boston Scientific, excluding registries) 7. Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis 8. Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics) 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 at anytime within the past 6 months.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 30 locations
Cardiology Associates of Northeast Arkansas
Jonesboro, United StatesUniversity of Southern California Hospital
Los Angeles, United StatesCardiovascular Consultants
Oakland, United States