Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF.
Bottom Line: Increased sympathetic activation and reduced parasympathetic tone are important pathophysiological contributors to the progression of heart failure, and are associated with poor outcome in patients.The study is powered to detect differences in the primary efficacy endpoint of change in left ventricular end systolic diameter.Secondary endpoints include ejection fraction, left ventricular volumes, quality of life scores, functional capacity, and changes in biomarkers.
Affiliation: Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.Show MeSH
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Mentions: The investigational vagal cuff lead is implanted in all patients by exposing approximately 4–6 cm of the vagus nerve on the right side of the neck. The lead is then tunnelled over the clavicle and connected to a pulse generator (Figure 2). The procedure can be performed under general or local anaesthesia by an appropriately trained and experienced vascular/cardiovascular surgeon or neurosurgeon. Although the recommendation is to use general anaesthesia, the surgical team may decide to use local anaesthesia if there is concern about patient safety. Based upon the clinical experience of vagal nerve implants to treat epilepsy, the procedure will take 90 minutes or less to implant in most cases.
Affiliation: Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.