Back to resultsVAgal Nerve Stimulation: safeGUARDing Heart Failure Patients (VANGUARD)
Primary Purpose
Heart Failure With Reduced Ejection Fraction
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Equilia® Vagal Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction
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
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
Sites / Locations
- UCL St Luc
- Hôpital Européen Georges Pompidou
- CHRU Hôpital Pontchaillou
- CHU Rangueil
- Rikshospitalet
- Dedinje Cardiovascular Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treated with Equilia system
Arm Description
Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02113033
Brief Title
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
Acronym
VANGUARD
Official Title
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 7, 2014 (Actual)
Primary Completion Date
February 22, 2016 (Actual)
Study Completion Date
September 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Equilia VNS device
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treated with Equilia system
Arm Type
Experimental
Arm Description
Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead
Intervention Type
Device
Intervention Name(s)
Equilia® Vagal Nerve Stimulation
Other Intervention Name(s)
Device used: Equilia®
Intervention Description
Vagal Nerve Stimulation synchronized with cardiac activity
Primary Outcome Measure Information:
Title
The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
Description
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.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Hagege, MD, PhD
Organizational Affiliation
HEGP - Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL St Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHRU Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Rikshospitalet
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Dedinje Cardiovascular Institute
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
12. IPD Sharing Statement
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VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
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