VITARIA Registry Study

NCT02545582 | Suspended

• 1 other identifier: C-05
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Serious and non-serious adverse events, according to ISO 14155

  12 months

• LVEF

  Left ventricular ejection fraction

  12 months

Secondary Outcomes (6)

• LVESV

  12 months

• LVESV Index

  12 months

• NYHA Class

  12 months

• Quality of Life

  12 months

• Heart Rate

  12 months

Study Arms (1)

Therapy

Heart failure patients implanted with the VITARIA system

Device: VITARIA System

Interventions

VITARIA System DEVICE

Implantable vagus nerve stimulator

Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Willing and capable of providing informed consent according to national data privacy regulations
• Patients with NYHA class II/III
• 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
• Receiving optimal pharmacological heart failure therapy for at least 3 months
• Recent implantation of the VITARIA system, prior to device activation

You may not qualify if:

• Hospitalization for heart failure and/or required the use of Heart Failure intravenous therapy in the past 30 days
• Severe mitral and/or any aortic valve dysfunction
• History of acute coronary syndrome (ACS) in the past 90 days
• Stroke or transient ischemic attack (TIA) in the past 90 days
• Coronary Artery Bypass Surgery (CABG) in the past 90 days
• PCI in the past 90 days
• Surgery for Valve replacement (Aortic or mitral valve) in the past 90 days
• Left ventricular end diastolic diameter (LVEDD) \> 80 mm
• Patients who have had a cardiac resynchronization therapy (CRT) device implanted and have been actively treated with CRT for \< 12 months
• Patients that are scheduled for CRT
• Patients who are listed for heart transplant or expected to be candidates for heart transplant
• Patients on hemodialysis or peritoneal dialysis
• 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

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (1)

CRI GmbH

Munich, 80335, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Helmut Klein, MD

  CRI GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 31, 2017

Record last verified: 2016-03

Locations

DE (1)