Completed

MANAGE-HFHeartLogic Feature in CRT-D or ICD Devices for Heart Failure Management

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Study Aim

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.

What is being tested

HeartLogic ON

+ HeartLogic OFF

Device
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Placebo-Controlled
Interventional
Study Start: August 2017
See protocol details

Summary

Principal SponsorBoston Scientific Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleMultiple Cardiac Sensors for the Management of Heart Failure
NCT03237858
Principal SponsorBoston Scientific Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Cardiovascular DiseasesHeart DiseasesHeart Failure

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
ICD and CRT-D devices with HeartLogic alerts turned ON

Group II

Placebo
ICD and CRT-D devices with HeartLogic alerts turned OFF

Study 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

Suspended

Heart Center Research, LLC

Huntsville, United StatesOpen Heart Center Research, LLC in Google Maps
Suspended

Cardiology Associates of Northeast Arkansas

Jonesboro, United States
Suspended

University of Southern California Hospital

Los Angeles, United States
Suspended

Cardiovascular Consultants

Oakland, United States
Completed30 Study Centers