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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Vagal Nerve Stimulation synchronized with cardiac activity
UCL St Luc
Brussels, Belgium
Hôpital Européen Georges Pompidou
Paris, France
CHRU Hôpital Pontchaillou
Rennes, France
CHU Rangueil
Toulouse, France
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.
Time frame: 6 Months
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Rikshospitalet
Oslo, Norway
Dedinje Cardiovascular Institute
Belgrade, Serbia