Actively Recruiting
Renal Pelvic Denervation Pilot Trial for Uncontrolled Hypertension Using the Verve RPDTM System
Led by Verve Medical, Inc · Updated on 2026-01-08
60
Participants Needed
5
Research Sites
122 weeks
Total Duration
On this page
Sponsors
V
Verve Medical, Inc
Lead Sponsor
R
RQM+
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Verve Medical's RPDTM renal denervation system in patients with uncontrolled hypertension despite using two medications at therapeutic doses. This system uses a novel method called renal pelvic denervation (RPD), where a device is placed through the urinary tract into the renal pelvis to deliver radiofrequency energy that targets nerves in the renal pelvis walls. The study aims to assess the safety and effectiveness of this approach in improving blood pressure control. Participants are randomly assigned to either receive the active RPD treatment or a sham procedure that mimics all steps without activating the device. Both groups will continue their prescribed medical therapy for hypertension during the study. The study includes assessments at 2, 6, and 12 months after the procedure, with the option for sham patients to receive the active treatment after 12 months if eligible. Medication adjustments are restricted until after the 2-month primary endpoint and may be intensified after the 6-month visit if needed. During the study, participants will undergo ambulatory and office blood pressure measurements, kidney function tests, and monitoring for procedure-related complications and adverse events. These evaluations will occur at specified intervals up to two years following treatment. The study includes close safety monitoring and encourages medication adjustments as clinically indicated between one and two years post-procedure to help manage hypertension.
CONDITIONS
Brief Title
Renal Pelvic Denervation Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently taking 2 anti-hypertensive medications, including one targeting the renin-angiotensin system and one calcium channel blocker or thiazide diuretic
- Stable antihypertensive medication regimen for at least 30 days
- Ambulatory mean daytime systolic blood pressure of at least 135 mmHg
- Ambulatory daytime systolic blood pressure less than 170 mmHg and diastolic blood pressure less than 105 mmHg
- Office systolic blood pressure between 140 and 180 mmHg
You will not qualify if you...
- History of non-compliance with medical care or treatments
- History of atrial fibrillation
- Pregnant, breastfeeding, or planning to become pregnant
- Office systolic blood pressure 180 mmHg or higher and diastolic 110 mmHg or higher
- Untreated urinary tract infection
- Compromised renal collecting system preventing cystoscopy or pyelogram
- Pre-existing hydronephrosis, renal stones, or abnormal kidney anatomy
- Receiving dialysis or renal transplant recipient
- Presence of only one kidney or dominant unilateral kidney function below 35%
- Polycystic kidney disease
- Diabetes treated with SGLT2 inhibitors or GLP-1 agonists
- Persistent albuminuria or focal sclerosing glomerulosclerosis
- Taking clonidine, guanfacine, or methyldopa
- Known secondary causes of hypertension
- Evidence of hyperaldosteronism
- Glomerulonephritis, interstitial nephritis, or low kidney function (eGFR <45)
- Type I diabetes mellitus
- Significant valvular heart disease or recent heart events
- Orthostatic hypotension episodes in last 6 months
- History of symptomatic heart failure or cardiomyopathy
- Peripheral arterial disease with symptoms
- Any condition interfering with study conduct or safety
- Pulmonary hypertension or need for oxygen or ventilation
- Untreated severe obstructive sleep apnea
- Use of medications affecting blood pressure off-target
- Bleeding disorders
- Life expectancy less than 24 months
- Working night shifts
- Upper arm circumference over 20 inches
- Enrollment in another hypertension trial or prior renal denervation
- History of recurrent kidney stones in last 6 months
- History of narcotic or opiate abuse or chronic pain treated with such therapies
- Active uroepithelial cancer
- Implanted urinary sphincter or penile prosthesis
- Planned medical procedures interfering with blood pressure measurement or safety assessments within 12 months
- Conditions affecting blood pressure measurement accuracy
- Vulnerable populations such as incarcerated or cognitively challenged adults
- Pre-existing urological abnormalities or renal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants will undergo the renal pelvic denervation procedure or a sham procedure using the Verve RPDTM system alongside their active hypertension medication regimen.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for safety and effectiveness through blood pressure measurements, renal function tests, and assessments of adverse events.
Visits at 2, 6, and 12 months post-procedure (in-person)
Duration - Up to 2 years after initial procedure
Participants continue to be followed for up to 2 years to assess long-term safety, effectiveness, and adjustments in hypertension medication.
Additional visits between 12 and 24 months (in-person)
Trial Site Locations
Total: 5 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Panoramic Health / Southwest Kidney Institute, PLC
Surprise, Arizona, United States, 85374
Actively Recruiting
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
DaVita Clinical Research
Las Vegas, Nevada, United States, 89107
Actively Recruiting
Research Team
D
Dan Merz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here