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Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

RECOVER HF tests whether the VisONE System is safe and works to treat heart failure. It stimulates the diaphragm, the main muscle used for breathing. The study is for people with heart failure who have symptoms despite recommended medicines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Heart failure in NYHA class II or III: symptoms with usual or light activity, while taking the best recommended medicines.
  • QRS time of 130 milliseconds or less, measured by a test of the heart’s electrical signals.
  • Ejection fraction (EF) of 40% or less. This means the heart pumps out 40% or less of the blood in its main pumping chamber with each beat.

Who can't join

  • Walking less than 200 or more than 500 meters in 6 minutes; or an NT-proBNP blood test below 250 while taking loop water pills, or below 500 without them.
  • Resting heart rate above 140 while lying down; top blood pressure number below 80 or above 170; or kidney or liver blood tests outside the study limits.
  • Certain recent heart problems, strokes, heart procedures, or medicines that strengthen heartbeats; certain abnormal heart rhythms; reversible heart muscle disease not caused by poor blood flow; or serious heart valve disease.
  • Severe lung disease, high pressure in the lung arteries, excess fluid around the lungs, or lung fluid drainage in the past 6 months; a paralyzed diaphragm; disease of the sac around the heart; or nerve damage from diabetes.
  • An existing device that stimulates the diaphragm to help breathing; certain heart-support devices; or a need for, or use of, a working device that helps the heart’s chambers beat together.
  • Conditions that make small-cut surgery to reach the diaphragm unsafe; open belly surgery in the past year; a past chest or belly organ transplant; or medicines that weaken the immune system.
  • Body mass index (BMI) above 40; being in another study; expected survival of less than 1 year; or pregnancy or plans to become pregnant during the study.
  • Known allergies to implanted device materials, or an infection affecting the body that needed antibiotics through a vein in the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) * QRS duration ≤ 130 ms * EF≤ 40% 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: 1. Greater than mild mitral valve stenosis 2. Greater than moderate mitral valve regurgitation 3. Greater than mild tricuspid valve stenosis 4. Greater than moderate-severe tricuspid valve regurgitation 5. Greater than moderate aortic stenosis 6. Greater than moderate aortic regurgitation 7. Greater than mild-moderate pulmonic stenosis 8. 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

Study sites (4)

IN

OK

PA

TX