Boston Scientific has enrolled the first patients in its NECTAR-HF (neural cardiac therapy for heart failure) clinical trial. NECTAR-HF is a prospective, randomized, international clinical feasibility study designed to assess preliminary safety and efficacy of chronic vagal nerve stimulation in heart failure patients. The study will evaluate 96 patients with vagal nerve stimulator implants at multiple centers in Europe.
"Stimulating the vagus nerve in the cervical region is commonly used to treat epilepsy and depression; however, promising pre-clinical data show that this therapy may also help a large population of heart failure patients who are currently not candidates for heart failure device therapy," said principal investigator and Steering Committee chairman Faiez Zannad, M.D., Ph.D., professor of therapeutics and cardiology and director of cClinical Investigation Center at INSERM in Nancy, France.
Congestive heart failure affects nearly 23 million people worldwide, with approximately 2 million new patients diagnosed annually. Despite substantial advances over the past two decades in pharmacological and device therapy, heart failure remains one of the leading causes of morbidity and mortality in the U.S. and most European countries.