RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 270 participants

Interventions

• DEVICE: Synchronized Diaphragmatic Stimulation — Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.

Primary Outcomes

• Left ventricular End-Systolic Volume (LVESV) (6 months)
• Six Minute Hall Walk (6MHW) (6 months)
• Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL) (6 months)
• Major Adverse Respiratory and Cardiovascular Events (MARCE) (6 months)

Secondary Outcomes

• Left Ventricular Ejection Fraction (LVEF) (6 months)
• N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP) (6 months)
• Left ventricular End-Systolic Volume (LVESV) (12 months)
• Six Minute Hall Walk (6MHW) (12 months)
• Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL) (12 months)

Trial Locations

• University of Pennsylvania, Philadelphia, Pennsylvania, United States

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