The Symplicity HTN-2 trial is an international, multi-center, prospective, randomized, controlled study of renal denervation in patients with treatment-resistant hypertension.
The Symplicity renal denervation system is not approved by the U.S. Food and Drug Administration (FDA) for commercial distribution in the United States.
Renal denervation therapy is a minimally invasive, catheter-based procedure that modulates the output of nerves that lie within the renal artery wall and lead into and out of the kidneys.
One hundred and six (106) patients were randomly allocated in a one-to-one ratio to undergo renal denervation with previous anti-hypertensive medication treatment or to maintain previous anti-hypertensive medication treatment alone (control group) at 24 participating centers.
Also reported in the manuscript were 6 month results of 35 patients in the control group who received renal denervation after the primary endpoint was assessed at six months post randomization (referred to as the crossover group).