VITARIA Registry Study

Congestive Heart Failure Clinical Trial

Official title:

VITARIA Registry Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02545582
• Other study ID #: C-05
• Status: Suspended
• Phase: N/A
• First received: September 8, 2015
• Last updated: January 30, 2017
• Start date: August 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2016
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• VITARIA System
Implantable vagus nerve stimulator

Locations

Country	Name	City	State
Germany	CRI GmbH	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Serious and non-serious adverse events, according to ISO 14155	12 months
Primary	LVEF	Left ventricular ejection fraction	12 months
Secondary	LVESV	Left ventricular end-systolic volume	12 months
Secondary	LVESV Index	Left ventricular end-systolic volume index	12 months
Secondary	NYHA Class	New York Heart Association classification	12 months
Secondary	Quality of Life	Minnesota Living with Heart Failure Questionnaire	12 months
Secondary	Heart Rate	Mean heart rate, 24-hour ambulatory ECG	12 months
Secondary	Heart Rate Variability	SDNN, 24-hour ambulatory ECG	12 months