VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
This trial is active, not recruiting.
|Condition||heart failure with reduced ejection fraction|
|Treatment||equilia® vagal nerve stimulation|
|Start date||October 2014|
|End date||March 2016|
|Trial size||20 participants|
|Trial identifier||NCT02113033, NVNS01|
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|
|Bruxelles, Belgium||UCL St Luc||no longer recruiting|
|Paris, France||Hôpital Européen Georges Pompidou||no longer recruiting|
|Rennes, France||CHRU Hôpital Pontchaillou||no longer recruiting|
|Toulouse, France||CHU Rangueil||no longer recruiting|
|Oslo, Norway||Rikshospitalet||no longer recruiting|
|Belgrade, Serbia||Dedinje Cardiovascular Institute||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead
The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
time frame: 6 Months
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
|Official title||VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients|
|Principal investigator||Albert Hagege, MD, PhD|
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