VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

LivaNova6 sites in 4 countries15 target enrollmentOctober 7, 2014

ConditionsHeart Failure With Reduced Ejection Fraction

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Heart Failure With Reduced Ejection Fraction
Sponsor: LivaNova
Enrollment: 15
Locations: 6
Primary Endpoint: The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.

Registry

clinicaltrials.gov

Start Date

October 7, 2014

End Date

September 20, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

LivaNova

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF \< 40%
•Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen
•Optimal drug regimen as defined in the current European guidelines
•Sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
•Signed and dated informed consent

Exclusion Criteria

•Patient implanted with or eligible to cardiac pacing as per current guideline
•Risk for neck surgery in the electrode zone within a year after enrollment
•Patient with right carotid artery stenosis
•Symptomatic hypotension
•History of peptic ulcer disease or upper gastrointestinal bleeding
•Asthma, severe COPD, or severe restrictive lung disease
•Advanced Diabetes Mellitus
•Recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned)
•Recent cerebro-vascular event
•Significant valvulopathy

Outcomes

Primary Outcomes

The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.

Time Frame: 6 Months

Adverse device effects will be sub-classified into device-related or procedure-related, when the adverse event has a generic cause independent from the device itself and occurs within 30 days of the implant procedure.