The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device diagnostics that have an implanted commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).
The study is expected to be conducted at up to 20 centers located in the United States. Up to 400 subjects will be enrolled to yield up to 200 eligible subjects that meet screening criteria. This study will be conducted in subjects with an implanted, commercially available, Medtronic, CRT-D device. Each enrolled subject will be followed every 2 months from time of enrollment to end of the study.The study will end after the last enrolled subject completes the 12-month follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
79
Single Arm Study. Subjects will be managed using integrated diagnostics.
Phoenix Cardiovascular Research Group, LLC
Phoenix, Arizona, United States
Florida Heart Center
Ft. Pierce, Florida, United States
Baptist Heart Specialists Research
Jacksonville, Florida, United States
First Coast Cardiology
Jacksonville, Florida, United States
Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective)
The Integrated Diagnostic Medication Intervention Strategy was physician-directed and nurse-implemented and it was based on a heart failure risk score diagnostic feature of a Medtronic CRT-D device implanted in the patients with heart failure. Effectiveness of this intervention strategy was measured as the percentage of implemented interventions being effective. Once initiated, an Integrated Diagnostic Medication Intervention would be effective if all the following criteria were met: 1. The intrathoracic impedance of a subject recovered per defined criterion after completion of the Integrated Diagnostic Medication Intervention; 2. The subject had no HF-related event (as adjudicated by the CEC) during or in the next 14 days after completion of the Integrated Diagnostic Medication Intervention; 3. The subject had not experienced any adverse events that were related to the Integrated Diagnostic Medication Intervention per CEC adjudication and require medical care.
Time frame: 12 months post enrollment
Safety of the Integrated Diagnostic and Medication Management (i.e. Percentage of Implemented Interventions Being Safe)
The Integrated Diagnostic Medication Intervention Strategy was physician-directed and nurse-implemented and it was based on a heart failure risk score diagnostic feature of a Medtronic CRT-D device implanted in the patients with heart failure. Safety of this intervention strategy was measured as the percentage of implemented interventions being safe. Once initiated, the Integrated Diagnostic Medication Intervention Strategy would be regarded as being safe if all the following criteria were met: 1. The Integrated Diagnostic Medication Intervention applied to an episode was not terminated due to safety issues; 2. The Integrated Diagnostic Medication Intervention applied to an episode had not caused treatment-related adverse events (as adjudicated by the CEC).
Time frame: 12 months post enrollment
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South Miami Heart Specialists
Miami, Florida, United States
Cardiology Partners
Wellington, Florida, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Lindner Research Center
Cincinnati, Ohio, United States