Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
NCT Number: NCT06552637
Acronym: RECOVER-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Interventions: DEVICE: Synchronized Diaphragmatic Stimulation
Sponsor: VisCardia Inc.
Collaborators: Clinical Accelerator Ltd.|Duke Clinical Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 270
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-12

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.

Primary Outcome Measures: 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 6 months post-randomization from baseline than medical management alone., 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., 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., 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, 6 months
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 12 months