VITARIA Registry Study

NCT ID: NCT02545582

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-12-31

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.

Conditions

Congestive Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Therapy

Heart failure patients implanted with the VITARIA system

VITARIA System

Intervention Type: DEVICE

Implantable vagus nerve stimulator

Interventions

VITARIA System

Implantable vagus nerve stimulator

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cyberonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helmut Klein, MD

Role: PRINCIPAL_INVESTIGATOR

CRI GmbH

Locations

CRI GmbH

Munich, , Germany

Countries

Germany

Other Identifiers

C-05

Identifier Type: -

Identifier Source: org_study_id