RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure
VisCardia Inc.
Summary
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.
Description
Symptomatic Diaphragmatic Stimulation (SDS) is a novel extra-cardiac device for patients who have symptomatic heart failure. Elevated intracardiac pressures are the hallmark of heart failure (HF) and a key pathological driver of disease progression and limited exertional capacity. The degree of cardiac pressure elevation is determined by preload, afterload, and pericardial restraint. The pericardium restrains the heart, and the degree of restraint is determined by the pericardial structure itself and the intrathoracic pressure. This aspect of HF pathophysiology is among the fundamental drivers…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 DC…
Interventions
- DeviceSynchronized Diaphragmatic Stimulation
Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania