Synchronized Diaphragmatic Stimulation for Heart Failure
This study, called RECOVER HF, is testing a new device called Synchronized Diaphragmatic Stimulation (SDS) using the VisONE System for people with heart failure with reduced ejection fraction (HFrEF). This device works by gently stimulating your diaphragm (the muscle that helps you breathe) in sync with your heart. The goal is to improve how your heart fills and performs. You might be able to join if you have symptomatic heart failure (NYHA classes II/III), are already on optimal heart failure medications, and have an ejection fraction (EF) of 40% or less. The study will look at how the device affects your heart's pumping ability, your walking distance, and your quality of life after 6 months.
- Study design
- This is a randomized, double-blinded study, meaning some participants will receive the active treatment and others a control, without knowing which. It plans to enroll 270 participants.
- What's involved
- All participants will have a VisONE System implanted. The primary outcomes are measured at 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main study outcomes are measured at 6 months after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
At a glance
Conditions
NCT06552637
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Saint Francis Hospital
Tulsa, Oklahomastudy coordinator listed
Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgiastudy coordinator listed
Recruiting
University of Pennsylvania
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Lee R Goldberg, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Left ventricular End-Systolic Volume (LVESV)6 months
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.
- Six Minute Hall Walk (6MHW)6 months
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.
- Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)6 months
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.
- Major Adverse Respiratory and Cardiovascular Events (MARCE)6 months
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