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Clinical trial, registry launched to evaluate renal denervation in HF, other conditions
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Medtronic has announced the start of two clinical initiatives that will evaluate broader use of the Symplicity renal denervation system across multiple conditions.
The phase 2, SYMPLICITY-HF clinical trial is the first to examine renal denervation in patients with chronic HF and renal impairment. The study is designed to evaluate the safety and physiological response to renal denervation with the Symplicity system in this patient population. Researchers will enroll approximately 40 patients with chronic HF and renal impairment in Australia and Europe, according to information in a press release.
“The SYMPLICITY-HF clinical trial will examine whether regulating sympathetic activity through renal denervation may also provide benefit in patients with both HF and renal insufficiency, two other conditions characterized by hyperactive sympathetic nervous system drive,” Henry Krum, MBBS, PhD, director of cardiovascular research and education at Monash University, Australia, said in the release.
The multicenter, prospective, open-label Global SYMPLICITY Patient Registry will evaluate the long-term impact of renal denervation in more than 5,000 patients. The registry will facilitate the collection of real-world data on the safety, efficacy and outcomes of the Symplicity renal denervation system in patients with a number of conditions associated with hyperactive sympathetic nervous system drive, including treatment-resistant hypertension, HF, insulin resistant, chronic kidney disease and sleep apnea.
“Having one comprehensive platform will allow researchers to efficiently and effectively collect robust clinical data and gain important insights into the effects of renal denervation in other disease processes where increased sympathetic tone is believed to be important,” Michael Böhm, MD, PhD, president of the German Society for Cardiology, chairman of the department of internal medicine at University of Saarland, Homburg/Saar, Germany, and Global SYMPLICITY Registry co-chair, stated in the release.
Data from the registry and clinical trial will build upon other data on renal denervation in patients with treatment-resistant hypertension, according to the release.
The minimally invasive Symplicity renal denervation system consists of a flexible catheter and proprietary generator that together modulate the output of nerves lining the walls of the arteries leading to the kidneys. Although not yet approved by the FDA for commercial distribution in the US, the system has been commercially available in Australia and Europe since April 2010. According to the company, the Symplicity system has been used since 2007 to treat more than 2,000 patients with treatment-resistant hypertension worldwide. In August 2011, the FDA granted Medtronic approval to conduct SYMPLICITY-HTN-3, a US clinical trial of the system in patients with treatment-resistant hypertension.
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