I50
Conditions
Interventions
Group 1: Observational prospective clinical registry in patients with symptomatic heart failure and implanted VITARIA™ System. Assessments will be made during 12 months of post-titration chronic st
Sponsors
Cyberonics, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 or above 2.Willing and capable of providing informed consent according to national data privacy regulations 3.Patients with NYHA class II/III 4.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 5.Receiving optimal pharmacological heart failure therapy for at least 3 months 6.Recent implantation of the VITARIA™ System, prior to device activation
Exclusion criteria
Exclusion criteria: 1.Hospitalization for heart failure and/or required the use of Heart Failure intravenous therapy in the past 30 days 2.Severe mitral and/or any aortic valve dysfunction 3.History of acute coronary syndrome (ACS) in the past 90 days 4.Stroke or transient ischemic attack (TIA) in the past 90 days 5.Coronary Artery Bypass Surgery (CABG) in the past 90 days 6.PCI in the past 90 days 7.Surgery for Valve replacement (Aortic or mitral valve) in the past 90 days 8.Left ventricular end diastolic diameter (LVEDD) > 80 mm 9.Patients who have had a cardiac resynchronization therapy (CRT) device implanted and have been actively treated with CRT for < 12 months 10.Patients that are scheduled for CRT 11.Patients who are listed for heart transplant or expected to be candidates for heart transplant 12.Patients on hemodialysis or peritoneal dialysis 13. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Parameters for Analysis: Assessment of changes of •LVEF Assessment of •Adverse events (SAE, AE), according to ISO 14155 | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Parameters for Analysis: Assessment of changes of •LVESV and LVESV index •NYHA Class •Quality of life (Minnesota Living with Heart Failure Questionnaire) •24-hour Holter recording: - Heart rate (HR) - Supra-/ventricular arrhythmias - Heart rate variability (HRV) | — |
Countries
Germany
Contacts
Public ContactClaudia Genée
CRI GmbH
Outcome results
None listed