VisONE Heart Failure Study: Pilot

VisCardia Inc.15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure With Reduced Ejection Fraction, HFrEF

Interventions

VisONE ADSDEVICE

VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Kyiv City Heart Center

Kiev, Ukraine

Amosov National Institute of Cardiovascular Surgery

Kyiv, Ukraine

Outcomes

Primary Outcomes

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

Time frame: after 3 months of therapy

Secondary Outcomes

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

Time frame: after 3 and 12 months of therapy

Freedom from serious complications or adverse events during chronic therapy

Time frame: after 12 months of therapy

Data from ClinicalTrials.gov

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