RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.
Symptomatic Diaphragmatic Stimulation (SDS) is a novel extra-cardiac device for patients who have symptomatic heart failure. Elevated intracardiac pressures are the hallmark of heart failure (HF) and a key pathological driver of disease progression and limited exertional capacity. The degree of cardiac pressure elevation is determined by preload, afterload, and pericardial restraint. The pericardium restrains the heart, and the degree of restraint is determined by the pericardial structure itself and the intrathoracic pressure. This aspect of HF pathophysiology is among the fundamental drivers behind the SDS therapy concept. SDS induces a temporal modulation of intrathoracic pressure.. When synchronized with the cardiac cycle, SDS may improve cardiac filling, cardiovascular pressure conditions, and cardiac performance RECOVER HF is a prospective, randomized, doubled-blinded study of Synchronized Diaphragmatic Stimulation (SDS) delivered in an imperceptible manner in subjects with heart failure defined as New York Heart Association (NYHA) functional class II/III, left-ventricular ejection fraction (LVEF) \<=40%, and QRS duration \<=130ms despite receiving the appropriate heart failure guideline directed medical therapy (GDMT). All subjects will receive an implanted VisONE System. Two-weeks post implant subjects will be randomized in a 1:1 ratio into a SDS therapy active or control (SDS therapy inactive) arm with both arms receiving GDMT. At 6 months the control arm will have SDS therapy activated with all patients receiving therapy and GDMT throughout the remainder of the study period. The study will be conducted at up to 30 investigational sites in the United States and several outside the U.S. These centers will enroll subjects with the goal of randomizing approximately 270 subjects who meet the entry criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGLeft ventricular End-Systolic Volume (LVESV)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger percent improvement in LVESV at 6 months post-randomization from baseline than medical management alone.
Time frame: 6 months
Six Minute Hall Walk (6MHW)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in 6MHW at 6 months post-randomization from baseline than medical management alone.
Time frame: 6 months
Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in MLWHF QOL at 6 months post-randomization from baseline than medical management alone.
Time frame: 6 months
Major Adverse Respiratory and Cardiovascular Events (MARCE)
To demonstrate the safety of the VisONE System by analyzing Major Adverse Respiratory and Cardiovascular Events (MARCE) occurring within 6 months post implant for the rate, severity and association with the device or procedure (goal \>70% freedom): * Cardiovascular Death * Stroke * Cardiac Arrest * Interaction with cardiac rhythm device requiring permanent termination of SDS therapy * Acute Heart Failure Decompensation * Infection requiring device/lead explant * Diaphragmatic dysfunction leading to a clinically significant reduction is respiratory function * Inadequate SDS therapy delivery requiring surgical intervention * Injury to abdominal organs requiring surgical intervention * Pneumothorax * Hemothorax
Time frame: 6 months
Left Ventricular Ejection Fraction (LVEF)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in LVEF at 6 months post-randomization from baseline than medical management alone.
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Time frame: 6 months
N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger reduction in NT-proBNP (log-10 transformed) at 6 months post-randomization from baseline than medical management alone.
Time frame: 6 months
Left ventricular End-Systolic Volume (LVESV)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger percent improvement in LVESV at 12 months post-randomization from baseline than medical management alone.
Time frame: 12 months
Six Minute Hall Walk (6MHW)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in 6MHW at 12 months post-randomization from baseline than medical management alone.
Time frame: 12 months
Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in MLWHF QOL at 12 months post-randomization from baseline than medical management alone.
Time frame: 12 months
Left Ventricular Ejection Fraction (LVEF)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in LVEF at 12 months post-randomization from baseline than medical management alone.
Time frame: 12 months
N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger reduction in NT-proBNP (log-10 transformed) at 12 months post-randomization from baseline than medical management alone.
Time frame: 12 months