VITARIA Registry Study

This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.

Study Overview

• Status: Suspended
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: VITARIA System

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80335
    • CRI GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic heart failure, NYHA class II/III with LVEF≤40%

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Therapy; Heart failure patients implanted with the VITARIA system	Device: VITARIA System; Implantable vagus nerve stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Serious and non-serious adverse events, according to ISO 14155	12 months
LVEF	Left ventricular ejection fraction	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cyberonics, Inc.
• Investigators: Principal Investigator: Helmut Klein, MD, CRI GmbH

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: C-05