VITARIA Registry Study | NCT02545582

Studies
VITARIA Registry Study

NCT02545582

Sponsor

Cyberonics, Inc.

Status

Suspended

Last Update Posted

Jan 31, 2017Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Congestive Heart Failure

Interventions

VITARIA System

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Aug 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Sep 8, 2015

First Submission Date that Met QC Criteria

Sep 8, 2015

First Posted Date

Sep 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Therapy		Heart failure patients implanted with the VITARIA system	Device: VITARIA System

Name	Type	Description	Arm Group Labels	Other Names
VITARIA System	Device	Implantable vagus nerve stimulator	Therapy

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
LVESV	Left ventricular end-systolic volume	12 months
LVESV Index	Left ventricular end-systolic volume index	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases