VITARIA Registry Study

Study Overview
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Brief Summary
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This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.

Detailed Description
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Observational prospective clinical registry in patients with symptomatic heart failure and implanted with the VITARIA System. Assessments will be made during 12 months of post-titration chronic stimulation. The registry will collect patient- and device follow-up data in clinical routine practice at baseline, 3, 6 and 12 months. Clinical routine safety of the therapy will be assessed by the incidence of procedure and device-related events. Clinical routine efficacy will be assessed by changes in cardiac function and heart failure symptoms.

Official Title
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VITARIA Registry Study

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: VITARIA System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and capable of providing informed consent according to national data privacy regulations Patients with NYHA class II/III LVEF≤40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, documented less than 12 weeks before implantation of VITARIA system Receiving optimal pharmacological heart failure therapy for at least 3 months Recent implantation of the VITARIA system, prior to device activation Exclusion Criteria: Hospitalization for heart failure and/or required the use of Heart Failure intravenous therapy in the past 30 days Severe mitral and/or any aortic valve dysfunction History of acute coronary syndrome (ACS) in the past 90 days Stroke or transient ischemic attack (TIA) in the past 90 days Coronary Artery Bypass Surgery (CABG) in the past 90 days PCI in the past 90 days Surgery for Valve replacement (Aortic or mitral valve) in the past 90 days Left ventricular end diastolic diameter (LVEDD) > 80 mm Patients who have had a cardiac resynchronization therapy (CRT) device implanted and have been actively treated with CRT for < 12 months Patients that are scheduled for CRT Patients who are listed for heart transplant or expected to be candidates for heart transplant Patients on hemodialysis or peritoneal dialysis Patients with diabetes (type I or type II) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin A1c (HbA1c) above 8.0% in the past 3 months

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Therapy<br>Heart failure patients implanted with the VITARIA system | Device: VITARIA System<br>* Implantable vagus nerve stimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Serious and non-serious adverse events, according to ISO 14155 | 12 months | 
| LVEF | Left ventricular ejection fraction | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVESV | Left ventricular end-systolic volume | 12 months | 
| LVESV Index | Left ventricular end-systolic volume index | 12 months | 
| NYHA Class | New York Heart Association classification | 12 months | 
| Quality of Life | Minnesota Living with Heart Failure Questionnaire | 12 months | 
| Heart Rate | Mean heart rate, 24-hour ambulatory ECG | 12 months | 
| Heart Rate Variability | SDNN, 24-hour ambulatory ECG | 12 months |