VisONE Heart Failure Study: Pilot
- Conditions
- Heart Failure With Reduced Ejection Fraction, HFrEF
- Interventions
- Device: VisONE ADS
- Registration Number
- NCT03484780
- Lead Sponsor
- VisCardia Inc.
- Brief Summary
The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system for 12 months.
- Detailed Description
This 12 month study is intended to validate the early benefits observed with Asymptomatic Diaphragmatic Stimulation (ADS) as a primary form of heart failure therapy with low rates and severity of adverse effects. Medical refractory symptomatic heart failure patients with reduced ejection fraction and no evidence of arrhythmias or ventricular dysynchrony will undergo laparoscopic implantation of the VisONE™ implantable system comprised of a pulse generator and two leads, programmed to deliver cardiac-gaited diaphragmatic stimulation pulses at asymptomatic outputs. Patients will be followed in pre-specified durations of 1,3,6 and 12-months using a series of evaluations of hemodynamic, echocardiographic, heart failure status, diaphragmatic function, implanted system data and standard safety measures including adverse events, for comparison with their baseline values. The results are intended to be used for designing a subsequent larger study for performing statistical power calculations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VisONE ADS VisONE ADS Patients implanted with a VisONE stimulator and leads for receiving continual Synchronized Diaphragmatic Stimulation
- Primary Outcome Measures
Name Time Method Freedom from serious complications or adverse events during procedural recovery and acute therapy after 3 months of therapy The following serious complications and adverse events will be analyzed for their rate and severity and compared to other implantable device systems
* Excessive procedural or implanted system morbidity
* Procedural or implanted system events resulting in unscheduled patient hospitalizations and surgical intervention
* Incidences resulting in physician choice to permanently discontinue therapy
- Secondary Outcome Measures
Name Time Method Freedom from complications or adverse events during chronic therapy after 3 and 12 months of therapy The following adverse events will be analyzed for their rate and severity and compared to other implantable device systems
* Procedural or implanted system events resulting in adverse patient symptoms
* Degradation of respiratory function by spirometer measures associated with procedure or implanted system
* Adverse events due to procedural or implanted system complications correctable by non re-operative means including system reprogramming or other readjustmentsFreedom from serious complications or adverse events during chronic therapy after 12 months of therapy The following serious complications and adverse events will be analyzed for their rate and severity and compared to other implantable device systems
* Excessive procedural or implanted system morbidity
* Procedural or implanted system events resulting in unscheduled patient hospitalizations and surgical intervention
* Incidences resulting in physician choice to permanently discontinue therapy
Trial Locations
- Locations (3)
Kyiv City Heart Center
🇺🇦Kiev, Ukraine
Amosov National Institute of Cardiovascular Surgery
🇺🇦Kyiv, Ukraine
Tbilisi Heart and Vascular Clinic
🇬🇪Tbilisi, Georgia