VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

Heart Failure With Reduced Ejection Fraction Clinical Trial

— VANGUARD  

Official title:

VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113033
• Other study ID #: NVNS01
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2014
• Last updated: March 12, 2018
• Start date: October 7, 2014
• Est. completion date: September 20, 2016

Study information

• Verified date: March 2018
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 20, 2016
• Est. primary completion date: February 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF < 40%

2. Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen

3. Optimal drug regimen as defined in the current European guidelines

4. Sinus rhythm, with spontaneous heart rate = 60bpm at the time of enrollment

5. Signed and dated informed consent

Main 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

• Advanced Renal failure

• Previous heart transplant or current LVAD device therapy

• Life expectancy < 1 year for non-cardiac cause

• Patient included in another clinical study that could confound the results of this study

• Inability to understand the purpose of the study or to perform the procedures of the study

• Unavailability for scheduled follow-up

• Age of less than 18 years or under guardianship

• Pregnancy

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Device:
• Equilia® Vagal Nerve Stimulation
Vagal Nerve Stimulation synchronized with cardiac activity

Locations

Country	Name	City	State
Belgium	UCL St Luc	Bruxelles
France	Hôpital Européen Georges Pompidou	Paris
France	CHRU Hôpital Pontchaillou	Rennes
France	CHU Rangueil	Toulouse
Norway	Rikshospitalet	Oslo
Serbia	Dedinje Cardiovascular Institute	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

Belgium,  France,  Norway,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.	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.	6 Months