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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
Manage-HF Phase I
Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.
Time frame: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit
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Heart Center Research, LLC
Huntsville, Alabama, United States
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States
University of Southern California Hospital
Los Angeles, California, United States
Cardiovascular Consultants
Oakland, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Emory University Hospital
Atlanta, Georgia, United States
Parkview Hospital, Inc.
Fort Wayne, Indiana, United States
Community Health Network
Indianapolis, Indiana, United States
...and 20 more locations