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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated with Equilia system | Experimental | Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equilia® Vagal Nerve Stimulation | Device | Vagal Nerve Stimulation synchronized with cardiac activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Hagege, MD, PhD | HEGP - Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCL St Luc | Brussels | 1200 | Belgium | |||
| Hôpital Européen Georges Pompidou |
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Equilia VNS device
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| Paris |
| 75015 |
| France |
| CHRU Hôpital Pontchaillou | Rennes | 35033 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| Rikshospitalet | Oslo | 0027 | Norway |
| Dedinje Cardiovascular Institute | Belgrade | 11040 | Serbia |