NCT06552637 · VisCardia Inc.
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
(RECOVER-HF)
What this study is about
RECOVER HF is a clinical study designed to evaluate the safety and effectiveness of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.
View original scientific description
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.
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 outcome measures
Left ventricular End-Systolic Volume (LVESV)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
- QRS duration ≤ 130 ms
Exclusion criteria
- Baseline 6 minute walk test \> 500 meters or \< 200 meters
- NT-proBNP\< 250 if on loop diuretics, or NT-proBNP \< 500 if not on loop diuretics
- Supine resting heart rate \> 140 bpm
- Systolic blood pressure \< 80 mmHg or \> 170 mmHg
- Serum creatinine \> 2.5 mg/dL
- Serum hepatic function 3x ULN
- Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF (\> 24 hours), symptomatic NSVT or DCCV
- Any inotropic drug treatment within the previous 3 months
- Bradycardia (heart rate \< 50 beats/min), atrial arrhythmias with rates \> 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy \>10% present during screening
- Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy \> 10% documented within the previous 3 months
- Reversible non-ischemic cardiomyopathy
- Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined by the site cardiologist as:
- Greater than mild mitral valve stenosis
- Greater than moderate mitral valve regurgitation
- Greater than mild tricuspid valve stenosis
- Greater than moderate-severe tricuspid valve regurgitation
- Greater than moderate aortic stenosis
- Greater than moderate aortic regurgitation
- Greater than mild-moderate pulmonic stenosis
- Greater than moderate pulmonic regurgitation
- Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys \>70 mmHg at rest
- Severe COPD, other respiratory or lung diseases where FEV \< 50%
- Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months
- Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray
- Pericardial disease
- Diabetic neuropathy
- Existing diaphragmatic stimulation for respiration assist
- Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months); or CRT that is indicated or implanted and functional
- Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician
- Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.
- Previous open laparotomy within 1 year
- Previous thoracic or abdominal organ transplant
- Drug induced immuno-suppression
- Body mass index \> 40
- Enrollment in a concurrent investigation / clinical study
- Having a life expectancy of \<1 year due to any condition
- Pregnant or planning a pregnancy during the study period
- Known allergies to implantable device materials
- History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months
Where
- Philadelphia, Pennsylvania
Collaborators
Clinical Accelerator, Duke Clinical Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations