Actively Recruiting
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
Led by VisCardia Inc. · Updated on 2026-03-31
270
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
Sponsors
V
VisCardia Inc.
Lead Sponsor
C
Clinical Accelerator
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- NYHA classes II or III on optimal Guideline Directed Medical Therapy (GDMT)
- QRS duration 64 130 ms
- Left ventricular ejection fraction (EF) 64 40%
You will not qualify if you...
- Baseline six minute walk test greater than 500 meters or less than 200 meters
- NT-proBNP less than 250 if on loop diuretics, or less than 500 if not on loop diuretics
- Supine resting heart rate greater than 140 beats per minute
- Systolic blood pressure less than 80 mmHg or greater than 170 mmHg
- Serum creatinine greater than 2.5 mg/dL
- Serum hepatic function more than 3 times upper limit of normal
- Unstable angina, acute myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, cerebrovascular accident/transient ischemic attack, persistent atrial fibrillation longer than 24 hours, symptomatic nonsustained ventricular tachycardia or direct current cardioversion within the previous 3 months
- Use of any inotropic drug treatment within the previous 3 months
- Bradycardia with heart rate less than 50 beats per minute, atrial arrhythmias with rate greater than 100 beats per minute, sustained ventricular tachycardia or frequent ventricular ectopy greater than 10% during screening
- Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy greater than 10% documented within the previous 3 months
- Reversible non-ischemic cardiomyopathy
- Valvular disease requiring intervention within 12 months or significant valve disease as determined by the site cardiologist including 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, or greater than moderate pulmonic regurgitation
- Severe primary pulmonary disease including pulmonary arterial hypertension with systolic pulmonary artery pressure greater than 70 mmHg at rest
- Severe chronic obstructive pulmonary disease or other lung diseases with forced expiratory volume less than 50%
- Presence of more than small pleural effusion or history of pleural drainage within 6 months
- Known or suspected diaphragmatic paralysis confirmed by chest x-ray
- Pericardial disease
- Diabetic neuropathy
- Existing diaphragmatic stimulation for respiratory assistance
- Presence of left ventricular assist device, baroreflex activation therapy, cardiac contractility modulation, interatrial shunt devices, temporary mechanical cardiac assist devices within 3 months, or cardiac resynchronization therapy indicated or implanted and functional
- Contraindications to laparoscopic access to diaphragm
- Known intra-abdominal pathology increasing risk of laparoscopic diaphragm access
- Previous open laparotomy within 1 year
- Previous thoracic or abdominal organ transplant
- Drug-induced immunosuppression
- Body mass index over 40
- Enrollment in another clinical investigation
- Life expectancy less than 1 year due to any condition
- Pregnancy or planning pregnancy during study
- Known allergies to implantable device materials
- History of systemic infection requiring intravenous antibiotics within 3 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
P
Patricia Arand, Ph.D.
CONTACT
P
Peter Bauer, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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