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 Boston Scientific VNS system is investigational. It consists of the investigational vagal cuff lead (NCT Lead; Boston Scientific Corporation, St. Paul, MN, USA) and of an implantable pulse generator (PrecisionTM; Boston Scientific Corporation). The NCT lead (see Figure 1) is a single lead with a bipolar, helical cuff, with an active anode and cathode, as well as a non-active strain relief cuff.
Affiliation: Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.