Heart Failure With Reduced Ejection Fraction, HFrEF
Conditions
Keywords
Implantable Heart Failure Device Therapy, Asymptomatic Diaphragmatic Stimulation
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.
Interventions
DEVICEVisONE ADS
VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation
Sponsors
Clinical Accelerator
University of Glasgow
University Hospital, Zürich
Stiftung für Herz-und Kreislaufkrankheiten
VisCardia Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Independent data review and analysis by the University of Glasgow Department of Biostatistics
Intervention model description
Patients implanted with the VisONE implantable system for delivering chronic Asymptomatic Diaphragmatic Stimulation (ADS).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 readjustments |
| Freedom 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical composite of heart failure and cardiac function | after 0, 1, 3, 6 and 12 months of therapy | The following outcomes will be analyzed determine the potential therapeutic impact on clinical heart failure management * NT Pro-BNP blood levels to assess heart failure status * Improvements to cardiac output, stroke volume or left ventricular filling * Improvements to left ventricular volumes or ejection fraction * Improvements to heart failure status, 6 minute hall walk, or assessment by heart failure questionnaire |
Countries
Georgia, Ukraine
Outcome results
None listed