Status:
COMPLETED
Multiple Cardiac Sensors for the Management of Heart Failure
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03237858
Start Date
August 30 2017
End Date
July 21 2020
Last Update
March 27 2024
Active Locations (30)
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1
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
2
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States, 72401
3
University of Southern California Hospital
Los Angeles, California, United States, 90033
4
Cardiovascular Consultants
Oakland, California, United States, 94609