Renal Pelvic Denervation Pilot Trial

Hypertensive patients frequently fail to have blood pressure optimally controlled, even with use of multiple medicines. The risk of chronically uncontrolled hypertension are substantial. Several clinical trials demonstrate the potential utility of renal denervation to improve blood pressure control as an adjunct to medications, yet the results of the technology and associated procedures have proven inconsistent. The RICH Pilot trial will evaluate the safety and effectiveness of Verve Medical's RPDTM renal denervation system for hypertensive patients with uncontrolled blood pressure despite use of two medications at a therapeutic dose. The novelty of the RPDTM system relates to its placement via natural orifice into the renal pelvis (bilaterally) for delivery of radiofrequency energy to ablate the nerves that pass through the outer wall of the renal pelvis, a technique referred to as renal pelvic denervation (RPD). Safety and effectiveness assessments will include measurement of ambulatory and automated office blood pressure, renal function, procedural complications and all adverse events. These randomized, double-blind, sham-controlled assessments will be conducted 2-, 6- and 12-months following the index procedure. Following completion of the 12-month assessments, sham treated subjects may receive open-label therapy if they meet the original inclusion/exclusion criteria, with all subjects followed for a total of 2 years. Up until the Month 6 assessment is complete, anti-hypertensive medical therapy is not to be altered unless required by significant worsening of a hypertensive related disease or due to a hypertensive emergency. Following completion of the Month 6 assessments, blinded investigators will be permitted and encouraged to intensify anti-hypertensive medication(s) if clinically indicated, as described further in the protocol. Between years 1 and 2, investigators will continue to be encouraged to intensify anti-hypertensive therapy for subjects not at goal.