Renal Pelvic Denervation Pilot Trial
Verve Medical, Inc
Summary
The RPD 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).
Description
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…
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Currently taking 2 anti-hypertensive medications (NOTE: no changes to medications allowed until after 2-month primary endpoint). \- As recommended in ACC/AHA 2017 Guideline,2 subjects are to be taking one anti-hypertensive antagonizing the renin-angiotensin system, including ACE inhibitor, ARB or renin inhibitor. Second drug should either be a calcium channel blocker (amlodipine preferred) or a thiazide diuretic. 2. Stable antihypertensive medical regimen for at least 30 days. 3. Ambulatory mean daytime SBP ≥135 mmHg. 4. Ambulatory daytime SBP \<170 and DBP \<105 mm…
Interventions
- DeviceRPD
Renal Pelvic Denervation
- DrugActive hypertension medical therapy
Prespecified two medication regimen for control of hypertension
Locations (5)
- University of Alabama at BirminghamBirmingham, Alabama
- Panoramic Health / Southwest Kidney Institute, PLCSurprise, Arizona
- University of MinnesotaMinneapolis, Minnesota
- Mayo ClinicRochester, Minnesota
- DaVita Clinical ResearchLas Vegas, Nevada