Tests a device that stimulates the diaphragm in heart failure
Tests a diaphragm stimulation device in adults with reduced-ejection-fraction heart failure.
Plain-language title generated from the registry record
Registry title: Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
Key facts
- Where
- Houston, Indianapolis, Philadelphia, and Tulsa, United StatesSee the 4 sites
Where in United States
- Baylor College of MedicineHouston, United StatesTaking people
- Ascension St. Vincent HospitalIndianapolis, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Saint Francis HospitalTulsa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- VisCardia Inc.
- Trial code
- NCT06552637
- Record updated
- 23 October 2026
- Original 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.Read full original descriptionShow less
RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure
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.
Inclusion: NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) for 3 months; EF≤ 40%; At the time of consent, willing and able to comply with protocol requirements, including attending all required visits; Willing to participate in the study and able to sign an informed consent form; ≥18 years of age at the time of consent.
Exclusion: Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, AF (episodes > 24 hours), symptomatic NSVT or DCCV; Any inotropic drug treatment within the previous 3 months; Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy > 10% documented within the previous 3 months; Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months; Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months); Previous open laparotomy within 1 year; Previous thoracic or abdominal organ transplant; Drug induced immuno-suppression; Enrollment in a concurrent investigation / clinical study; History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months; Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT; Supine resting heart rate > 140 bpm; Bradycardia (heart rate < 50 beats/min), atrial arrhythmias with rates > 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy >10% present during screening; 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 FEV1 < 50%; Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray; Pericardial disease; Non-cardiac condition substantially impairing ambulation of 6-minute hall walk test interpretation; Having a life expectancy of <1 year due to any condition; Known allergies to implantable device materials; Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to AHA/ACC/ESC guidelines for the treatment of congestive heart failure; Serum creatinine > 2.5 mg/dL; Serum hepatic function 3x ULN; 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; Systolic blood pressure < 80 mmHg or > 170 mmHg; Reversible non-ischemic cardiomyopathy; Existing diaphragmatic stimulation for respiration assist; 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; Body mass index > 40; Pregnant or planning a pregnancy during the study period.