Two Programs Launched to Examine Renal Denervation System
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Medtronic has announced the start of two clinical programs that are designed to evaluate its renal denervation system across multiple conditions.
The first is the Global Symplicity Patient Registry, which will evaluate the real-world, long-term impact of a renal denervation system (Symplicity) in 200 centers worldwide. The prospective, open-label registry will include more than 5,000 patients who have conditions associated with hyperactive sympathetic nervous system drive, including resistant hypertension, HF, insulin resistance, sleep apnea and chronic kidney disease.
The second is the SYMPLICITY-HF phase 2 study, which will be the first clinical trial to examine renal denervation in patients with chronic HF and renal impairment. The trial will include approximately 40 adult patients with chronic HF and renal impairment in Europe and Australia. The studys principal investigators are Henry Krum, MBBS, PhD, director of cardiovascular research and education at Monash University, Victoria, Australia, and Michael Böhm, MD, chief of cardiology at Saarland University, Homburg/Saar, Germany.