Overview

This trial is active, not recruiting.

Condition heart failure with reduced ejection fraction
Treatment equilia® vagal nerve stimulation
Phase phase 2
Sponsor Sorin Group
Start date October 2014
End date December 2015
Trial size 20 participants
Trial identifier NCT02113033, NVNS01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead
equilia® vagal nerve stimulation Device used: Equilia®
Vagal Nerve Stimulation synchronized with cardiac activity

Primary Outcomes

Measure
The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
time frame: 6 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
Principal investigator Albert Hagege, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Sorin Group.