VITARIA Registry Study

Suspended

• Conditions: Congestive Heart Failure
• Interventions: Device: VITARIA System

• Registration Number: NCT02545582
• Lead Sponsor: Cyberonics, Inc.

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-10
• Status Verified: 2016-03
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31
• Primary Completion: 2018-08
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Therapy	VITARIA System	Heart failure patients implanted with the VITARIA system

Primary Outcome Measures

Name	Time	Method
Adverse Events	12 months	Serious and non-serious adverse events, according to ISO 14155
LVEF	12 months	Left ventricular ejection fraction

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CRI GmbH; 🇩🇪 Munich, Germany