Clinical trial NCT02545582: VITARIA Registry Study
Official title: VITARIA Registry Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Congestive Heart Failure
Lead sponsor: Cyberonics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic heart failure, NYHA class II/III with LVEF≤40%

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 12 months
measure: LVEF
timeFrame: 12 months
Secondary outcomes:
measure: LVESV
timeFrame: 12 months
measure: LVESV Index
timeFrame: 12 months
measure: NYHA Class
timeFrame: 12 months
measure: Quality of Life
timeFrame: 12 months
measure: Heart Rate
timeFrame: 12 months
measure: Heart Rate Variability
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: CRI GmbH
Study officials:
affiliation: CRI GmbH
name: Helmut Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: