VisONE Heart Failure Study: Pilot

Study Overview
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Brief Summary
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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
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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.

Official Title
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VisONE Pilot Study of Chronic Asymptomatic Diaphragmatic Stimulation for Patients With Symptomatic Heart Failure, Reduced Ejection Fraction and Preserved Ventricular Synchrony

Conditions
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Heart Failure With Reduced Ejection Fraction, HFrEF

Intervention / Treatment
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* Device: VisONE ADS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria NYHA class II/III medical refractory despite guideline indicated heart failure medications Sinus rhythm with <10% ectopy EF ≤ 35% NT-proBNP > 500 (250 if on loop diuretics) Exclusion Criteria 6MHW >500 m or < 200 m Resting HR > 140 bpm SBP <80 mmHg or > 170 mmHg Serum creatine > 2.5 mg/dL Ventricular dyssynchrony by ECG with QRS ≥ 140ms Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT, sustained VT or VF, or DCCV within 3 months Intermittent inotropic drug treatment Existing pacemaker or indications for a pacemaker Severe primary pulmonary disease including pulmonary arterial hypertension or severe COPD, or other respiratory or lung diseases where FEV < 50% or any condition with severe diaphragmatic dysfunction Previous open laparotomy within 1 year or contraindications to laparoscopy, as determined by implanting physician Known or active intra-abdominal infections, or known intra-abdominal pathology Previous thoracic or abdominal organ transplant, transplant waiting list Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients implanted with the VisONE implantable system for delivering chronic Asymptomatic Diaphragmatic Stimulation (ADS).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VisONE ADS<br>Patients implanted with a VisONE stimulator and leads for receiving continual Synchronized Diaphragmatic Stimulation | Device: VisONE ADS<br>* VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation<br>* Other names: Synchronized Diaphragmatic Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from serious complications or adverse events during procedural recovery and acute 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 | after 3 months of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from complications or adverse events during chronic 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 readjustments | after 3 and 12 months of therapy | 
| Freedom from serious complications or adverse events during chronic 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 | after 12 months of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Heart Failure Device Therapy, Asymptomatic Diaphragmatic Stimulation