Congestive Heart Failure
Conditions
Brief summary
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
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.
Interventions
DEVICEVITARIA System
Implantable vagus nerve stimulator
Sponsors
Cyberonics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and capable of providing informed consent according to national data privacy regulations 2. Patients with NYHA class II/III 3. 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 4. Receiving optimal pharmacological heart failure therapy for at least 3 months 5. Recent implantation of the VITARIA system, prior to device activation
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 | Description |
|---|---|---|
| Adverse Events | 12 months | Serious and non-serious adverse events, according to ISO 14155 |
| LVEF | 12 months | Left ventricular ejection fraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NYHA Class | 12 months | New York Heart Association classification |
| Quality of Life | 12 months | Minnesota Living with Heart Failure Questionnaire |
| LVESV | 12 months | Left ventricular end-systolic volume |
| Heart Rate Variability | 12 months | SDNN, 24-hour ambulatory ECG |
| Heart Rate | 12 months | Mean heart rate, 24-hour ambulatory ECG |
| LVESV Index | 12 months | Left ventricular end-systolic volume index |
Countries
Germany
Outcome results
None listed