VITARIA Registry: Observational prospective clinical registry in patients with symptomatic heart failure and implanted Cyberonics VITARIA™ System
- Conditions
- I50Heart failure
- Registration Number
- DRKS00009292
- Lead Sponsor
- Cyberonics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Parameters for Analysis:<br>Assessment of changes of<br>•LVEF<br>Assessment of<br>•Adverse events (SAE, AE), according to ISO 14155<br>
- Secondary Outcome Measures
Name Time Method Major Parameters for Analysis:<br>Assessment of changes of<br>•LVESV and LVESV index<br>•NYHA Class<br>•Quality of life (Minnesota Living with Heart Failure Questionnaire)<br>•24-hour Holter recording: <br>- Heart rate (HR) <br>- Supra-/ventricular arrhythmias<br>- Heart rate variability (HRV)<br><br>